rapid situation assessment of bts in...

Rapid Situation Assessment of

Blood Transfusion Services

in India

2014

National AIDS Control Organization (NACO)),

Ministry of Health and Family Welfare, Government of India

in collaboration with

U.S Centers for Disease Control and Prevention (HHS/CDC/CGH)

Division of Global HIV/AIDS, India

and

Christian Medical Association of India (CMAI)

of 115

FOREWORD

Shri. Lov Verma I.A.S Secretary, Ministry of Health & Family Welfare, Govt. of India

FOREWORD

Blood Transfusion Service is a vital part of modern health care system without which

medical care is impossible. It is essential to ensure provision of safe, clinically effective and

of, appropriate and consistent quality of blood and blood products to all those who are in

need of transfusion. This involves a highly complex operation that requires a holistic and

comprehensive approach in planning, designing and operationalizing Blood Transfusion

Services in India.

The advent of National AIDS Control Programme in India, has made substantial

improvements in blood transfusion services during the last two decades in terms of,

availability of quality blood and blood products, infrastructure, equipment, and service

delivery that resulted in, increased access to safe and quality blood and blood products

across the country. Due to the concerted efforts, availability of safe blood increased from 44

lakh units in 2007 to 93 lakh units by 2013; during this time HIV sero-reactivity declined

from 1.2% to 0.2%; and Voluntary blood donation increased substantially. However, there

are still gaps and challenges in ensuring availability and accessibility of blood to all those are

in need that need to be reviewed and analyzed.

Therefore, a comprehensive of the review of the existing situation of Blood Transfusion

Services in the country is required which will help the country to take corrective measures

and to develop appropriate programmes and policies in the future, so that universal access

to safe blood and blood products and work towards self-sufficiency will be a reality.

This report on “Rapid Situation Assessment of Blood Transfusion Services in India” will

definitely be a useful guide and reference material that explains the current situation of

blood transfusion services, the gaps, challenges and recommendations to improve the blood

transfusion services in the country.

I would like to congratulate Dr. S D Khaparde, DDG, the BTS team at NACO and other

organizations who contributed to the development of this report.

(Shri. LovVerma I.A.S

of 115

PREFACE

Dr Sunil D. Khaparde

Deputy Director General

Basic services & Blood Safety Division, National AIDS Control Organisation (NACO)

PREFACE

Since the inception of National AIDS Control programme in 1992, the Blood Safety

Programme in India under the National AIDS Control Organization (NACO) has been making

significant strides towards ensuring access to safe and quality blood and blood products to

all those who are in need of transfusion. The goals and objectives of the programme are to

ensure, provision of safe and quality blood even to far-flung remote areas of the country.

NACO took continuous steps to strengthen the blood banks across the country by providing

equipment, consumables, manpower and capacity building. The efforts to modernizing

blood-banks, establishing model blood-banks, and setting up blood-storage centers in rural

areas have indeed improved the quality of blood transfusion services in the country.

The current phase of the NACP IV (2012 -2017)emphasizes blood safety that aims to

support 1,300 blood banks and aims to achieve 90,00,000 blood units from DAC supported

Blood Banks and 95% voluntary blood donation in 2016-17. The key strategies under NACP

IV are, strengthening management structure of blood transfusion services and

implementing National EQAS for all participating labs at district and above for HIV related

diagnostic services. NACP-IV also aims to explore the possibilities of streamlining the

coordination and management of blood banks and blood transfusion services; and new

initiatives such as, the establishment of Metro Blood Banks and Plasma Fractionation Centre

are also planned.

The Rapid Situation Assessment of Blood Transfusion Services in India was carried out with

the specific objectives of reviewing and understanding the existing structure, systems,

programmes, services, legal and policy environment; the extent to which the programmes

have achieved its expected outcomes; the factors facilitating or hindering achievements;

gaps and challenges; and formulate recommendations that can inform programmes and

policies.

This report includes the results of a comprehensive desk review and assessment carried out

through site visits across the country. Besides, the report highlights the key issues,

challenges and recommendations especially, the recommendations of the experts and state

programme officers.

I take this opportunity to extend my sincere appreciation to the U.S. Centers for Disease

Control and Prevention-Division of Global HIV/AIDS (CDC-DGHA), India Office, and Christian

Medical Association of India (CMAI) for providing technical assistance and support in

completing the assessment and developing the report.

(Dr Sunil D. Khaparde)

of 115

Acknowledgment

The report on “Rapid Situation Assessment of Blood Transfusion Services in India” has been

developed by the Blood Transfusion Services Division, NACO, Ministry of Health and Family

Welfare under the guidance and active leadership of Shri. Lov Verma, I.A.S, Secretary,

Health.

I would like to express my sincere gratitude to Shri K.B. Aggarwal, IAS, Joint Secretary, NACO

for his continuous encouragement and support to complete this activity. I would like to

record my thanks to Dr. Shobini Rajan, Dr. Shanoo Mishra, STI Division, NACO and other

team members for their valuable support in providing direction for the guidelines.

I would like to acknowledge my appreciation and thanks to all those who have reviewed and

provided their valuable comments. I take this opportunity to express my sincere thanks to

all the experts who were part of the assessment through site visits.

I am pleased to extend my sincere thanks to the U.S. Centers for Disease Control and

Prevention-Division of Global HIV/AIDS (CDC-DGHA), India and Christian Medical Association

of India (CMAI) for providing technical assistance and support in completing the assessment

and developing this report.

Dr Sunil D. Khaparde,

Deputy Director General,

Basic services & Blood Safety Division, NACO

of 115

Table of Contents

Acronyms 7

List of Figures 8

List of Tables 9

1. Blood Transfusion Services in India – Background 10

2. Purpose and Objectives 12

3. Methodology 14

3.1. Desk Review 14

3.2. Site Visits 15

I. SECTION A 17

4. Review Results 18

4.1. The Evolution of Blood Transfusion Services in India 18

4.2. Current Blood Transfusion Programmes in India 21

4.2.1. Structure and Systems of BTS services in India 21

4.2.2. Resource Availability 30

4.2.3. Blood Banks and the volume of blood collected

32

4.2.4. Demand and Supply 35

4.2.5. Transfusion Transmitted Infections 37

4.2.6. Blood Transfusion Services Components under NACP 42

4.2.6. (i). Augmentation of Voluntary Blood Donation 43

4.2.6. (ii). Access to safe and Quality Blood 49

4.2.6. (iii). Quality Assurance in BTS Services 51

4.2.6. (iv). Monitoring and Evaluation Systems in BTS services 54

of 115

4.2.6. (v). Appropriate Use of Blood and Blood Products – Clinical

use of Blood and Blood products

56

4.2.6. (vi). Technological Innovations in Blood Transfusion Services

in India

61

4.2.6. (vii). Integration with the Health System and Convergence

with NRHM, other departments and Ministries

64

4.2.6. (viii). Efficient Supply Chain Management and Quality

Assurance

66

4.2.6. (ix). Legal, Regulatory &Policy Dimension of BTS in India 68

4.2.6. (x). Ethical Issues in BTS Services

71

II. SECTION B 73

5. Site Specific Observations 74

III. SECTION C 87

6. Issues, Challenges and Recommendations 88

7. Key recommendations of experts based on site specific observations 99

8. Key areas for improvement and suggestions by State Programme

Officers

102

9. Conclusion 103

10. References 104

of 115

Acronyms

ADR :Adverse Drug Reaction

BB : Blood Banks

BCT : Blood Components for Transfusion

BCSU : Blood Components Separation Unit

BSC : Blood Storage Centers

BTS : Blood Transfusion Service

CDSCO : Central Drugs standard Control Organization

CLAA : Central License Approving Authority

CHC : Community Health Centre

DAC :Department of AIDS Control

DLBB : District Level Blood Bank

ELISA : Enzyme Linked Immuno sorbent Assay

EQAS : External Quality Assessment System

FRU : First Referral Units

GDBS :Global Database on Blood Safety

GOI : Government of India

HBV : Hepatitis B Virus

HCV : Hepatitis C Virus

HIV : Human Immunodeficiency Virus

ICTC : Integrated Counselling and Testing Centre

IPC :Indian Pharmacopoeia Commission

PvPI : Pharma covigilance Program of India

INR : Indian Rupee

NRL :National Reference Laboratory

NACO : National AIDS Control Organization

NACP : National AIDS Control Programme

NGO : Non-Governmental Organization

NRHM : National Rural Health Mission

SRL : State Reference Laboratory

PCR : Polymerase Chain Reaction

PEP : Post Exposure Prophylaxis

PPTCTC : Prevention of Parent to Child Transmission

PDMP : Plasma-derived medicinal products

PFF : Plasma for fractionation

PHC : Primary Health Care Centre

QA : Quality Assurance

RNA : Ribonucleic acid

SOP : Standard Operative Procedure

SIMS : Strategic Management Information System

TQM : Total Quality Management

TTI : Transfusion Transmitted infection(s)

VNRD : Voluntary Non-Remunerated Donation

WHA : World Health Assembly

WHO : World Health Organization

of 115

List of FiguresList of FiguresList of FiguresList of Figures

Figure 1 Structure of Blood Transfusion Services in India 26

Figure 2 DAC- BTS Infrastructure 28

Figure 3 Volume of Tesk Kits supplied to BBs 31

Figure 4 Blood Banks per 1,000,000 population 32

Figure 5 Blood Banks per 1,000,000 population 33

Figure 6 Type of Blood Collection 2012-13 33

Figure 7 Type of Blood Collection 2012-13 33

Figure 8 Total Blood Units per 100,000 population - State wise 34

Figure 9 Volume of Blood Collection based on Type of BBs 34

Figure 10 % of Blood collection in Govt. Blood Banks 35

Figure 11 Total Blood Units Collected 36

Figure 12 Total Units per 100,000 population 37

Figure 13 Total Blood Units Collected 37

Figure 14 TTIs Positivity (2010-11 to 2012-13) (All Reporting Units) 38

Figure 15 TTIs Positivity (2010-11 to 2012-13)(DAC Supported) 38

Figure 16 HIV Positivity- State wise 2012-13 (All Reporting Units) 38

Figure 17 HIV Positivity Voluntary Vs Replacement donors 39

Figure 18 HIV Positivity Voluntary Vs Replacement(DAC supported) 39

Figure 19 Hep B Positivity-State wise 2012-13 39

Figure 20 Hep B Positivity Voluntary vs Replacement 40

Figure 21 Hep B Positivity Voluntary vs Replacement(DAC Supported) 40

Figure 22 Hep C Positivity-State wise 2012-13 40

Figure 23 VDRL Positivity 2012-13 – State wise 41

Figure 24 Hep C Positivity Voluntary Vs Replacement 41

Figure 25 VDRL Positivity Voluntary Vs Replacement(ALL Reporting Units) 41

Figure 26 Malaria Positivity 2012-13 41

Figure 27 Proportion of Voluntary Blood Donation 44

Figure 28 % of Voluntary Blood Donation - (SIMS) 44

Figure 29 State wise proportion of VBD (2012-13) 45

Figure 30 State wise proportion of VBD 2012-13 45

of 115

Figure 31 VBD in BBs – Gender 46

Figure 32 VBD in BBs – Gender(DAC Supported) 46

Figure 33 VBD in Camps – Gender 46

Figure 34 VBD in Camps – Gender 46

Figure 35 Total Blood Collection Vs VBD from camps 46

Figure 36 Total Blood Units Vs VBD from Camps(DAC Supported) 47

Figure 37 Number of Blood donation Camps 47

Figure 38 Blood Donation Camps 47

Figure 39 Repeat Donation 48

Figure 40 Repeat Donation 48

Figure 41 Repeat Donation as proportion of Total Voluntary Blood

Donation

58

Figure 42 Packed Cells Prepared and Supplied % 58

Figure 43 Packed Cells Prepared and Supplied % 58

Figure 44 Platelets Prepared and Supplied % 58

Figure 45 Platelets Prepared and Supplied % (DAC Supported) 58

Figure 46 Fresh Frozen Plasma prepared and Supplied % 58

Figure 47 Fresh Frozen Plasma prepared and Supplied %(DAC Supported) 58

Figure 48 Cryoprecipitate Prepared and Supplied 59

List of TablesList of TablesList of TablesList of Tables

Table – 1 Types of Blood Transfusion Facilities 23

Table – 2 Factors contributing to lack of access to safe blood and blood

products in India

51

of 115

Blood Transfusion Services in IndiaBlood Transfusion Services in IndiaBlood Transfusion Services in IndiaBlood Transfusion Services in India

1. Background

Blood Transfusion Service (BTS) is an essential part of modern health care system without

which medical care is impossible (Pal, Kar, Zaman, & Pal, 2011). The provision of safe and

adequate blood and blood products at national level is the responsibility of the

government/national health authority of each country (Ramani, Mavalankar, & Govil, 2007).

Blood safety is essential to ensure that a patient who comes for treatment is not made

sicker by another illness (Hemogenomics, 2013). These products must be safe, clinically

effective and of appropriate and consistent quality (WHO, 2012b). The Twenty-eighth

World Health Assembly resolution number WHA 28.72 of 1975 urged member countries to

promote the development of national blood services based on voluntary non remunerated

donation of blood; to enact effective legislation governing the operation of blood services

and to take other actions necessary to protect and promote the health of blood donors and

of recipients of blood and blood products (WHO, 1975).

However, provision of safe and quality blood for a country like India involves a highly

complex operation involving various stakeholders and the magnitude and complexity of

issues raises several challenges(GOI, 2003). This requires a holistic and comprehensive

approach in planning, designing and operationalizing the BTS services. It is important to

ensure coordination between the blood transfusion services, health services and hospitals,

educational institutes, religious, social and industrial organizations, mass media and other

stakeholders including general public. The system should also ensure adequate input into

the legislative, regulatory, technical, social and cultural aspects of making this life saving

product accessible and safe.

While the need for blood is universal, millions of patients requiring transfusion do not have

timely access to safe blood and there is a major imbalance between developing and

industrialized countries in access to safe blood (WHO, 2009a). Besides, there is a huge

inequity in the availability of blood within countries, with urban areas having more access to

the majority of blood available. Even if sufficient blood is available, many are exposed to

of 115

avoidable, life-threatening risks through the transfusion of unsafe blood. In order to ensure

universal access to safe and quality blood, achieve 100% voluntary blood donation and to

ensure 100% quality-assured testing of donated blood, strengthening the implementation of

key strategies is essential. It is also imperative to optimize blood usage, develop quality

systems in the transfusion chain, strengthen the workforce, adopt new developments and

build effective partnerships(WHO, 2008a).

Though Blood Transfusion services in India have advanced significantly over the last 50

years, the AIDS pandemic has, in fact, brought into focus the importance of safe blood

transfusion(Ray, Chaudhary, & Choudhury, 2000a). Especially, since the inception of

National AIDS Control Programme Phase one (NACP 1992-1999) that had 30 per cent of its

project cost focussing on blood safety, there have been significant improvements in the

availability of quality of blood/blood products, infrastructure, equipment, and service

delivery in India. Though the screening of donated blood was made mandatory since 1989,

an estimated 85% of the nation's blood supply was not being screened for HIV (Baweja H,

1992). In 1993, infected blood and blood products accounted for the second largest

number(13%) of recorded AIDS cases (Correa; & Gisselquist, 2005); Blood banks in remote

areas did not have access to screening facilities and the employees did not have skills to

undertake testing themselves. A significant 24% of the country’s blood supply was from the

private sector that heavily relied on professional blood donors for 94% of blood collected

(NACO, 1993) (Asthana, 1996). The situations have changed dramatically now. Several

legislative changes and court directions during the last two decades have significantly

improved the situation, and the National Blood Policy adopted in 2002 gives overall

direction for the effective functioning of Blood Transfusion Services (BTS) in the

country(NACO, 2007d).

Over the years, the World Health Assembly resolutions such as, Utilization and supply of

human blood and blood products in 1975; Global health-sector strategy for HIV/AIDS in

2003; Blood safety: proposal to establish World Blood Donor Day in 2005; the Melbourne

declaration on 100% voluntary non-remunerated donation of blood and blood components

availability, safety and quality in 2010; and the Rome Declaration on achieving

self-sufficiency in safe blood and blood products, based on voluntary non-remunerated

donation of blood products in 2013 have guided the principles and key elements for

of 115

developing the current national blood transfusion system in the country and reaffirmed the

achievement of self-sufficiency in blood and blood products based on voluntary non-

remunerated blood donation(VNRD) (WHO, 2013c) (WHO, 2010d) (WHO, 2010a) (WHO,

2009b) (WHO, 2005) (WHO, 1975). In specific, the recent Rome declaration reiterated the

national authorities to incorporate the goal of self-sufficiency in safe blood based on VNRD

into national health policies; introduce appropriate legislation; provide sufficient financial

and other resources; and introduce strategies and measures to establish appropriate quality

systems (WHO, 2013b).

Due to the continuous efforts in India, the availability of safe blood increased from 44 lakh

units in 2007 to 93 lakh units by 2013; during this time HIV sero-reactivity also declined from

1.2% to 0.2%; and Voluntary blood donation increased substantially (NACO, 2013).

Nevertheless, there are still gaps and challenges in ensuring availability and accessibility of

blood to all those are in need. For instance, some districts in the country still do not have

government supported blood centers. India is able to collect only 9 million units against an

annual demand of 12 million units; only around 70% is from voluntary blood donors

(Agarwal, 2012); Lack of human resources and lack of adequate quality management

systems in the majority of blood banks continue to be areas requiring further attention

(Lowalekar & Ravichandran, 2013; Singh, 2007). There are several organizational and

management issues hindering the effective service provision in the country (Nanu, 2001). In

addition, there is inequity in the availability, accessibility and quality of blood transfusion

services in India. This calls for a review of the existing situation of Blood Transfusion

Services in the country which will help the country to take corrective measures and to

develop and implement programmes and policies in the future.

2. Purpose and Objectives

The purpose of this assessment is to understand the existing situation of blood transfusion

services in India, identify gaps, best practices, emerging challenges and provide inputs to

evidence based inputs to National Programme.

of 115

The specific objectives are,

• To review the existing structure, systems, programmes, services, legal and policy

environment.

• To review and document the extent to which the programmes have achieved its

outputs and contributed to its intended outcomes

• To understand the factors facilitating or hindering achievements

• Document lessons learned and challenges

• Formulate recommendations that can inform programmes and policies.

The key areas such as, the structure; systems (organizational/management and

operational); programmes; resources (human, financial and materials), strategies,

services/activities, policies, legislation, regulations, social, ethical and cultural dimensions

were reviewed based on the following framework or guiding principles.

• Availability and its distribution. Are they available? Is there need based distribution?

Factors hindering or facilitating the availability or non- availability?

• Adequacy - Are they adequate? – Are they adequate to all? Factors hindering or

facilitating the adequacy?

• Appropriateness and Relevance - Are the structure or services appropriate/relevant?

Are they meeting the needs of the different situation and demands?

• Accessibility - Are those who are in need of it, able to access services? (Economic,

geographical, social and cultural access). Factors hindering or facilitating the

adequacy?

• Quality - Is the quality up to the standard? Is quality equally distributed? Reasons for

lack of quality? Factors hindering or facilitating quality?

• Effectiveness of service provision and efficiency- Factors hindering or facilitating the

effectiveness or efficiency?

• Sustainability- Are the existing service provision sustainable?

• In addition these, this review also looked at the Supply side issues such as human

resources, financial resources, supply chain management issues, policy and legal

environment and health system related issues and challenges.

of 115

3. Methodology

In order to achieve the objectives, a two pronged strategy of desk review and site specific

observations has been adopted.

3.1 Desk Review

The desk review is mainly dependent on the secondary sources that include,

• Analysis of secondary data

o SIMS data provided by Department of AIDS Control(DAC)

o Data extracted from the DAC Annual Reports

o Data from other M and E reports, documents on the topic

o CMIS reports

The SIMS data provided from the Department of AIDS Control was analyzed in terms of total

units collected, voluntary blood donation, TTIs, components separated and utilized, etc.

These were analyzed for the blood banks in the country including both Private and Public

sector; as well as for the DAC supported Blood banks.

• Review of documents at both global and country levels. Global documentation

included

• World Health Statistics Report.

• Blood safety and availability Fact Sheet.

• WHO Global Strategic Plan 2008-15

• Global database on blood safety – WHO

• UN Reports, Guidelines etc.,

Country level documents are drawn from a number of sources, including

• The thematic reviews, presentations

• Documents and guidelines developed by DAC and other multilateral and

bilateral agencies.

• Annual work-plans,

of 115

• Country programme documents, programme review meeting reports,

national surveys, national reviews, annual and quarterly reports by DAC and

other relevant organizations.

• Published journal articles in peer-reviewed journals.

• Other unpublished documents

3.2 Site visits by DAC approved experts

The site specific observations included site visits to 15 facilities across five zones covering

nine states. A sample of 3 DAC supported blood banks per zone was selected for the

assessment. Blood banks in each zone were identified from three levels of health care

delivery systems such as Tertiary, Secondary and Primary. Wherever possible, the FRUs

linked to mother blood bank were also visited. Adequate attention was given in the

selection of blood banks to ensure geographical distribution and representation of

government and voluntary/charitable blood banks.

The site specific observations also included interviews with a Joint Director – Blood Safety

and a State Drug Controller in each zone. The tools used for the Assessment were,

• Check List for Blood Banks

• Checklist for Blood Storage Centres

• Interview Schedule for Joint Director-Blood Safety

• Interview Schedule for State Drug Controller.

3.3 Challenges and limitations

The desk review has limitation in terms of establishing the counterfactuals and attribution

of outputs as there are constraints for comparison that might lead to possible biases. These

limitations were addressed through triangulation of information and data wherever

possible.

Other limitations are,

1. The total DAC supported blood banks are 1137 (NACO, 2014b), however, 1039 blood

banks were found as DAC supported in the SIMS data, based on the cross verification

with the list of Blood banks provided by DAC. During the course of this exercise, it is

found that the information available at the periphery, state and at the national level is in

variance. Efforts are being made by DAC to address these information gaps.

of 115

2. Lack of baseline and end line data at output and outcome levels

3. Reports are very often descriptive.

3.4 Data Analysis

The quantitative data were analyzed using SPSS version 20. The Population Census 2011 of

India by Government of India was used for analysis. The qualitative part of the assessment

explored to understand the various aspects of blood transfusion services. Thematic analysis

was done for qualitative data. The predetermined themes and the themes that emerged

significantly from the interviews were listed, and the contents/concepts/views under each

theme were extracted systematically.

Time period for Onsite Assessment

13th

February to 5th

March 2014

of 115

SECTION – A

Desk Review Results

of 115

4. Review Results

4.1 The Evolution Blood Transfusion Services India

The evolution of blood transfusion services was one of the most important of medical

advances derived from World War I (Hess & Thomas, 2003). A well-organized Blood

Transfusion Service (BTS) is a vital component of any health care delivery system. For

quality, safety and efficacy of blood and blood products, well-equipped blood centers with

adequate infrastructure and trained manpower are essential requirements (Sarkar, Philip,

Kumar, & Yadav, 2012).

Since the advent of the HIV epidemic, blood services in India have come under increased

scrutiny, much resources have been spent, and services have improved considerably over

the last two decades (Bray & Prabhakar, 2002). The Blood Safety Programme in India began

to take shape in 1992 with the establishment of the National AIDS Control Organization

(NACO) with three major focus areas that were, surveillance; health education &

information; and screening of blood and blood products. This was the time the Transfusion

transmitted HIV/AIDS in mid-1980s raised the several questions of blood safety (Das B K,

2011). In 1989-90, a program on "Prevention of infection and modernization of blood

banking services" was commenced. In the same year, under the Drugs and Cosmetics Act

HIV Testing was made mandatory prior to blood transfusion (Dhot, 2003). Three

laboratories viz. National Institute of Communicable Diseases (NICD) Delhi, National

Institute of Virology (NIV), Pune, and Christian Medical College Hospital (CMCH), Vellore

were notified to test HIV antibodies in human blood and human blood products. Since

trained technicians were not immediately available in blood banks to carry out the test for

HIV 1 & 2 antibodies, the Ministry of Health & Family Welfare notified Zonal Blood Testing

Centres, to act as testing labs for the blood banks to comply with this new requirement.

During 1992-93, the Drugs Controller General, India was vested with the power of Central

License Approving Authority (CLAA) to approve the license of notified drugs viz., blood and

blood products, fluids, vaccines and sera. The Drugs and Cosmetics Rules, 1945, framed

under the Drugs and Cosmetics Act, 1940 were amended in 1993 through which the

of 115

licensing of blood banks was brought under the dual authority of the state and central

government. The state licensing authority issues the license, while the Drug Controller

General (India) is the central license approving authority. The Drugs and Cosmetics Rules,

1945 were further amended in the years 1996, 1999 and 2001. In December 2001, a

notification was issued to regulate and streamline the blood storage centres, which helped

community health centres, small hospitals / nursing homes whose requirement is less than

2000 units of blood per annum.

The Supreme Court verdict in 1996 that directed the government to improve the blood

transfusion service resulted in establishing the National and State Blood transfusion Councils

(NBTC / SBTC) to develop policies and programs for bringing about improvements in blood

centres. In 1997, HIV counselling and testing services were started in India. In 2001, Testing

of blood for Hepatitis C Virus (HCV) antibodies was made mandatory. In 2002, the WHO

Guidelines on the Clinical Use of Blood was adopted by NACO. In the same year,

Government of India framed and adopted the National Blood Policy (NBP) (NACO, 2007d).

National AIDS Control Programme and Blood Safety

Each of the three phases of the National AIDS Control Programme(NACP) in India focused on

and emphasized, blood safety in the country (Prasannakumar, 2008). The NACP paved way

for revamping the blood collection, processing, and storage and distribution system in the

country. National and state blood transfusion councils were established; the National Blood

Transfusion Policy was formulated, and guidelines were developed covering all aspects of

blood donation, testing and storage. The NACP took initiatives and provided funds to states

to modernize existing blood banks and Zonal blood testing centres were set up. Professional

blood donation was banned. Component separation units were set up in very large blood

banks in order to address the increasing demand for safe blood.

Under NACP Phase I (1992-99), the NACO modernized 815 blood-banks and also set up 40

blood component separation facilities to promote the rational use of blood (Ramani,

Mavalankar, & Govil, 2009). NACO launched a scheme to modernize blood-banks by

providing assistance to states to upgrade and provide minimum facilities to blood-banks in

of 115

the public sector and those run by charitable organizations, such as Indian Red Cross

Society. NACO has also constituted Technical Resource Group (TRG) in 1997 to seek

guidance, advice and policy directions on various aspects of Blood Safety programme which

helped in improving the quality of blood transfusion services in the country

During NACP Phase II (1999-2004), efforts were taken to modernizing more blood-banks,

establishing model blood-banks, and setting up blood-storage centres in rural areas. By the

end of the second phase, the number of licensed blood banks increased to 1,230 including

82 blood component separation centres; and HIV transmission through blood was reduced

to less than two per cent from eight per cent when surveillance first started in the late

1980s. In addition to HIV testing, blood banks were required to test all donated blood for

Hepatitis C and an external quality assurance system for HIV testing was set up.

The specific objective of NACP phase III (2007-12) was to ensure the reduction in the

transfusion associated with HIV transmission to 0.5 %, while making safe and quality blood

available within one hour of its requirement in a health facility. The programme aimed to

bridge the gap between the demand for blood (8.5 million units annually) and supply (4.4

million units, of which only 52 % is through voluntary donation), and improve the quality of

blood. This was achieved by improving the quality, infrastructure for blood storage and

component separation; ensuring optimum use of blood and blood products as well as

autologous blood donation; promoting voluntary blood donation; and through a regulatory

and monitoring structure.

The current phase of the NACP IV (2012 -2017) also lays emphasis on blood safety that aims

to support 1,300 blood banks and aims to achieve 90,00,000 blood units from DAC

supported Blood Banks and 95% voluntary blood donation in 2016-17 (NACO, 2014d). The

key strategies under NACP IV are, strengthening management structure of blood transfusion

services and implementing National EQAS for all participating labs at district and above for

HIV related diagnostic services. NACP-IV aims to explore the possibilities of streamlining the

coordination and management of blood banks and blood transfusion services and new

initiatives such as the establishment of Metro Blood Banks and Plasma Fractionation Centre

are also planned with a budget of INR 818.80 crore for the period of 5 years (NACO, 2014f).

of 115

4.2. Current Blood Transfusion Programmes in India

4.2.1. The Structure and systems of Blood Transfusion Services in India

The Blood Safety Program in India has developed as a component of the National AIDS

Control Programme that has led to several advancements in terms of better policies,

increased infrastructure, facilities, quality and access to blood transfusion services. In

contrast to many western countries, Blood services have been a highly decentralized and

fragmented structures and operations in India (Ramani et al., 2007).

The Department of AIDS Control (DAC) under the Ministry of Health and Family Welfare,

Government of India and SACS aim at preventing the transmission of HIV and ensure 100%

screening of all collected blood units, providing training and financial assistance to blood-

banks for technical modernization for ensuring the quality of blood-banks (Ashavaid, 2012).

The National Blood Transfusion Council (NBTC) is the apex policy making body and has a

major role in the formulation of policy on safe blood-transfusion services in India. The

National and State Blood Transfusion Councils were established as registered societies

(Sarin, 2003) which are provided with necessary funds through National AIDS Control

Programme as well as by respective state governments. The National Blood Transfusion

Council provides policy direction and its decisions are implemented by the State Blood

Transfusion Councils. Licensing and monitoring of the blood-banks in India is the

responsibility of the Drug Controller General of India (Pal et al., 2011).

Currently, there are several types of blood banks in India which are licensed by Central

License Approving Authority (CLAA-DCG(I)) and State Licensing Authorities (SLA) of

respective States of the Country for safe blood supply under the requirements of Schedule F

part XII B and C of Drugs and Cosmetics Act 1940 and rules there under (Ramkishan et al.,

2012). There has been a different mix of competing independent and hospital-based

blood-banks of different levels of sophistication, serving different types of hospitals and

patients. These blood banks can be either in the government or the private sector. The

public bodies concerned with the organization and administration of blood services include

Central, State, and autonomous government institutes, municipal corporations, cantonment

boards, railway services, employee state insurance authorities, and the armed forces. In the

of 115

private sector, there are blood-banks run by, charitable trusts, independent commercially-

oriented private organizations, and specific non-government health organizations, such as

the Indian Red Cross Societies (IRCSs) (Ramani et al., 2009).

Functionally, blood transfusion services may be broadly categorized as,

• Hospital based blood bank

• Stand-alone blood bank

• Blood storage centres.

The key structures and their key function are mentioned below, (Refer Figure 1)

National Blood Transfusion Council

The National Blood Transfusion Council (NBTC), established and registered as societies in

1996, has the major advisory role in the formulation of policy on safe blood-transfusion

services in India, and it is supported by the Department of AIDS Control(DAC) (Ramani et al.,

2009). The NBTC is responsible for,

• Promoting Accreditation of blood banks

• Establishment of proper institutional mechanism for planning and implementation of

blood safety such as Regional Blood Transfusion Centres in every state

• Development of guidelines for constitution of hospital transfusion committee &

development of guidelines for operationalization of plasma fractionation facility in

the country (NACO, 2007d).

The national council in collaboration with the state blood transfusion councils inspects all

the blood banks at Public and Private sector facilities regularly for implementation of

"National Blood Safety Programme.

State Blood Transfusion Council

The State Blood Transfusion Council (SBTC)is also an autonomous body that is responsible

for formulation of policy, regulation and implementation of the entire range of activities

related to operation and requirements of blood banking system in the state and blood

transfusion services starting from grouping, cross matching, donor selection, collection of

blood, proper preservation, transportation, utilization, component separation and apheresis

of 115

(GOO, 2014);(GOM, 2005). The training of Blood Bank Officers, Laboratory Technicians,

Motivators and counsellors including the officials of RBTCs and rational use of blood are the

responsibility of the Council. Quality control of whole blood and blood products is one of

the activities of the Council (SBTC, 2013). However, Maharashtra and Nagaland are different

when it comes to the functioning of SBTC. Generally, SBTCs are operating under SACS except

in these states (Ramani et al., 2009).

Regional Blood Transfusion Centers (RBTCs)

RBTC is a blood bank approved by the SBTC taking into consideration the regional needs of

blood & components and the ability of RBTC in terms of premises, personnel and equipment

(Ramani et al., 2007). The objective of a regional blood transfusion centre (RBTC) is to

ensure a safe and quality blood and blood components to meet the needs of the patients in

the region and to assist health centres/hospitals in their appropriate use. As a mother blood

bank, the RBTC are mandated to support and strengthen the blood storage centres of the

region/area. The RBTCs will send regular and complete reports to SBTCs and they in turn,

direct them in planning regional blood programmes and in the use of standardized

techniques and procedures (GSBTC, 2013). The regional blood transfusion centre is

identified based on the amount of blood collected (more than 15,000 units per year)

(Ramani et al., 2009). 142 RBTC have been established so far, however, several states such

as Puducherry, Andaman and Nicobar Island, Dadra and Nagar Haveli, Daman and Diu, and

all northeastern states except Assam do not have any Regional Blood Transfusion Centres.

Table – 1: Types of Blood Transfusion Facilities

(DAC Supported)

Type of Facility 2008 -09 2009-10 2010 -11 2011-12 2012 - 13 2013 -2014

Blood Bank 1092 1103 1127 1,149 1118 1137

Model blood Bank 10 10 28 28 34 34

Blood Component

Separation Units 104 130 155 171 175 258

Major Blood Bank 0 0 0 0 167 180

District level blood

bank 0 0 0 0 742 665

of 115

DAC supported Blood Banks

Based on the volume, geographical coverage and the availability of blood transfusion

facilities, the DAC supported facilities are categorized as follows,

• Model blood Bank

• Blood Component Separation Units

• Major Blood Bank

• District level blood bank

• Regional Blood Transfusion Centre

Model Blood Banks

Model Blood Banks are higher level structures in the blood banking system which functions

as demonstration centres for the State in that they are set-up. According to DAC, blood

banks which collect more than 10,000 blood units per annum with training facilities for

Medical officers, Technicians and Nurses can be categorized as Model Blood Banks.

Currently, there are 34 Model blood banks are functioning. A state of art blood mobile van

has also been issued to each model blood bank to improve Voluntary collection in the states

within 200 kms of the model blood bank (NACO, 2013).

Blood Component Separation Units (BSCUs)

Blood banks that collect 5000 to 10000 blood units per annum with facilities for component

separation are categorized as BCSUs. The Blood Component Separation Units are primarily

aimed at component separation. During NACP II & III many district headquarters hospitals

blood banks (Major Blood banks) were upgraded as BCSU with the provision of

infrastructure and equipment for blood component separation. Currently, there are 258

Blood Component Separation Units (BCSU) functional in the country. Of these facilities, 34

facilities have additional facilities and are designated as Model blood banks. However Goa,

Daman and Diu and five out of seven northeastern states (Manipur, Nagaland, Mizoram,

Arunachal Pradesh, Sikkim, and Tripura) still do not have any BCSUs.

of 115

Major Blood Banks

Blood banks that collect 3000 to 5000 blood units per annum are categorized as major blood

banks. The number of Major Blood Banks (MBB) increased from 167 in 2012-13 to 180 in

2013-14. However several state including Puducherry, Ahmedabad, Andaman and Nicobar

Islands, Dadra and Nagar Haveli, Daman and Diu, Meghalaya, still do not have any MBB.

District level Blood Banks

Blood banks that collect less than 3000 blood units are categorized as District level Blood

banks, usually located at district hospitals. During NACP-I and NACP-II, blood banks in all

districts of the country were taken up under the scheme for modernization of blood banks.

Currently, 665 district level blood banks are functional throughout the country. Chandigarh,

Dadra and Nagar Haveli still do not have District level Blood Bank (DLBB) supported by DAC.

Metro Blood Banks

DAC has proposed to set up four Metro Blood Banks as Centres of Excellence in transfusion

medicine, in the cities of New Delhi, Mumbai, Kolkata and Chennai to improve the BTS in

India. These proposed blood banks will have State of the Art facilities with 100% Voluntary

Blood Donation, 100% blood components preparation, and capacity to process more than

one lakh units of blood annually.

of 115

Ministry of Health & Family Welfare

NATIONAL

LEVEL

Fig 1 – Structure of Blood Transfusion Services in

India

Sub-district

level

NBTC – National Blood Transfusion Council

DAC – Department of AIDS Control

NHM – National Health Mission

CDSCO – Central Drugs Standard Control Organisation

SBTC – State Blood Transfusion Council

SACS – State AIDS Control Society

SHS – State Health Society

SDCA – State Drug Control Administration

NBTC DAC

SBTC

NHM CDSCO

SACS

STATE

LEVEL

SDCA

Non DAC Supported Voluntary BB

Non DAC supported Private BB

SHS

DAPCU – District AIDS Prevention Control Unit

DHS – District Health Society

DDCA – District Drug Control Administration

BSC –Blood Storage Centres

BB – Blood Bank

DISTRICT

LEVEL

DAPCU DDCA DHS

Government BB

Charitable/ Voluntary BB

Private BB

Regional

Blood

Transfusion

Centre

BSC

Licensing

Legend

Coordination

Supervision & Funding

Technical guidance

Monitoring support

Licensing only

of 115

Blood Storage Centres (BSC)

In order to address the lack of availability of blood in rural areas, the policy was modified in

2001, allowing the establishment of blood-storage units in rural regions. It has provided the

exemption from obtaining the license to store, cross-match and issue Whole Human Blood I.

P. and / or its components to the First Referral Unit, Community Health Centre, Primary

Health Centre and any Hospital. Currently, there are Blood storage centres (BSCs).

However, there is still a lot to be achieved as it is given low priority in the states.

According to the FRU guidelines, blood-storage facility is one of the three critical

determinants as First Referral Units (FRUs) have been identified to deliver EmOC services

(GOI, 2004). As of March 2011, there were 2,891 FRUs (574 DH + 826 SDH+1491 CHCs) in

the country (GOI, 2011). The NACP phase III aimed to establish blood storage centres in

3222 CHCs with the equipment grant by RCH-II & annual recurrent grant by DAC and make

available refrigerated vans in 500 districts for networking with blood storage centres (NACO,

2007g). But, there are only 745 blood storage centres functioning across the country

(NACO, 2013). It was reported that FRUs were not fully operational due to lack of specialist

staff, infrastructure, equipment, medicines, and blood-transfusion facilities in 2001(Ramani

et al., 2009). It is estimated that if FRUs were equipped with the proper blood supply, they

could reduce maternal mortality by 30% (HINDU, 2007).

As per the Concurrent Evaluation of National Rural Health Mission (NRHM) in 2009, only

14% of the CHC were having blood storage facility, 74.1% of the District Hospitals have

Blood Bank/ Blood storage unit (GOI, 2013). According to Facility Survey 2007-08, though

52% of Community Health Centres (CHC) were designated as FRUs, only 9.1% had blood

storage facilities (IIPS, 2010) which indicated the huge gap in making blood accessible to the

rural population. Though the creation of blood storage centres in sub district level and first

referral units have resulted in better access to blood than previously, these are still not

available to all due to licensing and regulations as these blood storage centres are not

authorized to supply blood to other facilities.

of 115

Plasma Fractionation Centre

As envisaged by NACP phase III strategy plan, a large Plasma Fractionation Centre at

Chennai with processing capacity of 1.5 lakh litres annually is under process and expected to

function shortly. This is an INR 250-crore project which aims to ensure access of plasma

derivatives to those who are in need at affordable costs; that would also reduce the

dependence on importing from other countries. Through this initiative, the surplus plasma

will not be wasted and will be sent to the fractionating centres. However, the country

needs standards and guidelines for testing, processing and logistics; National guidelines on

Clinical use of plasma derived products (NACO, 2014c).

Voluntary Organizations in Blood Transfusion Services

Civil Society Organizations such as, NGOs, charitable and voluntary organizations play an

active role in Blood Transfusion Services in India. There are several blood banks in the

country being run by charitable and voluntary organization and, in specific; they are quite

active in promoting voluntary donation of blood.

Indian Red Cross Society

Red Cross/Red Crescent Societies in many countries, as auxiliaries to their governments,

play an important role in promoting safe and sustainable blood programmes. The Indian Red

Cross Society established in 1920 follows the same mandate. Their activities range from the

1092

1103

1127

1149

1118

1137

10 1028 28 34 34

104130

155171 175

258

0

50

100

150

200

250

300

10601070108010901100111011201130114011501160

2008 - 09 2009 - 10 2010 - 11 2011 - 12 2012 - 13 2013 - 14

Fig 2 - DAC- BTS Infrastructure

Blood Bank Model blood Bank Blood Component Separation Units

of 115

Plasma Fractionation Centre: To support the establishment of India’s first public-owned

plasma fractionation centre in Chennai.

Metro Blood Banks: To support the establishment of Support was provided for the

establishment of the four metro blood banks in Mumbai, Delhi, Kolkata and Chennai to

serve as centres of excellence for the blood transfusion system in India..

provision of the national blood service to systematic recruitment of voluntary blood donors,

the promotion of blood donation and advocacy for VBD, etc. They are involved in blood-

related activities at three levels such as, full blood services (collecting, testing, processing,

and distribution); Systematic recruitment of blood donors to the blood service; Promotion

and advocacy of blood donation. Promote safe, sustainable and equitable practices in the

development and administration of blood programmes. Indian Red Cross Society is one of

the important players in the Blood Transfusion Services in India. As of now, they have 166

blood banks across 14 states in India. IRCS provides blood to government hospitals and the

needy free of charge as well as to thalassemia children (IRCS, 2014).

Safe Blood Saves Lives Project

GIZ (Deutsche Gesellschaft für Internationale Zusammenarbeit) and the National AIDS

Control Organisation collaborated through the project titled “Safe Blood Saves Lives” in

ensuring the provision of adequate, safe and quality blood to every patient in the need of a

transfusion through a well-coordinated National Blood Transfusion System. GITEC

CONSULT GmbH - One of Germany’s leading consulting companies in development projects

was the implementing partner for the project. Stakeholders include the Government of

India, in particular the DAC, along with the National Blood Transfusion Council and the State

Blood Transfusion Council (GIZ, 2012). The key strategic areas of support were,

Private Sector Blood banks in India

Indian blood transfusion service is the largest in the South Asia region, and private sector

contributes a significant proportion of blood supply in the country (Choudhury, 2011).

According to Central Drugs Standard Control Organization, 61.2% (1564) of the blood banks

in the country were private blood banks which can be classified as follows from an

administrative point of view,

of 115

• Private hospital based

• Private stand-alone

Like private health care, blood transfusion service in the private sector is also unregulated.

Though private blood banking in India has philanthropy motive, it is not so in many cases

(Choudhury, 2009). Private sector heavily relied on professional blood donors, and there

are commercial motives, as well. The blood banks including private blood banks in India is

also reported having shortage of technical capability and lack of quality standards

(Choudhury, 2009). While the Department of AIDS Control supported blood banks are

required to follow specific guidelines and adhere to quality standards, supported by regular

monitoring and supervision, the private blood banks lack in these areas. Several licensed

private blood banks in the states do not report their blood collection details to the

respective SACS that lead to lack of monitoring and supervision of blood supply from the

blood banks to health care institutions (Ramani et al., 2009) (Ramani et al., 2007). This calls

for regulatory measures for collection and supply chain of blood and its components in

order to ensure adequate, safe and quality blood and blood products to those who access

private blood transfusion services.

4.2.2. Resource Availability

Ever since the National AIDS Control Programme Phase one (NACP 1992-1999) was initiated,

blood safety has been given much attention by the Government of India. The National AIDS

Control Organization (NACO) is responsible for blood safety while providing financial

assistance along with adequate training to staff and doctors. In addition to this, staffing

and materials (test kits, equipment, reagents) support are being provided to the DAC

supported blood banks in the country.

Financial Resources

The first phase of the Programme had INR 250.02 crore out of the INR 657.55 crore (38%

per cent of its project cost) focussing on blood safety (CAG, 2004). The third phase of the

project proposed INR 955 crore (8.24 percent of the project cost). Around INR 41 Crore were

exclusively proposed for blood safety promotional activities in NACP III phase (NACO, 2006).

The current National AIDS Control Programme NACP IV has allocated substantial resources

of 115

1000000

2000000

3000000

4000000

5000000

6000000

7000000

2010-11 2011-12 2012-13

Fig 3: Volume of Tesk Kits supplied to BBs

HIV Elisa HIV Rapid Hep B ELISA

HepB Rapid HepC Elisa HepC Rapid

for Blood Transfusion Services that comes around INR 818 crore(6.09 percent) out of the

INR 13,414 crore with the targets of supporting 1300 blood banks through which aiming to

achieve 90 percent of the total volume of blood collected in the country (NACO, 2014e).

Human Resources

The National AIDS Control Programme provides human resources support to all the DAC

supported blood banks that includes, Quality Assurance Manager, Technical Assistant, Lab

Technician and Counsellor. In addition to this, several training programmes on all aspects of

Blood Transfusion Services that aim to strengthen the capacity of the individual and

institutions involved in Blood Transfusion Services. The department of AIDS Control

identified 17 centres across the country to build the capacity of Blood Bank Medical Officers,

Technicians, Counselors, Nurses, Clinicians, Donor Motivators and Programme Officers of

SACS (NACO, 2013).

Equipment and Materials:

The DAC supports the blood banks in terms of procurement of equipment, blood bags,

Testing Kits and Reagents (HIV,

HBsAg, and HCV, Syphilis &

group regents) as well as the

recurring expenditure of

government blood banks and

those run by

voluntary/charitable

organizations, which were

modernized. In addition, it

provides IEC materials such as,

Donor-group Cards, Donor and camp organizer appreciation certificates, Voluntary Blood

Donation posters, Hand-outs etc. It also provides donors refreshment and camp expenses

support to all DAC supported blood banks for their Voluntary Blood Donation Promotion

programmes (NACO, 2013).

of 115

However, literature highlights that Blood Transfusion Services in India is highly decentralized

and the Country lack many essential resources like manpower, adequate infrastructure and

financial resources which emphasizes the need for more allocation of resources (NACO,

2007d) (NACO, 2007h)

4.2.3. Blood Banks and the volume of blood collected

According to Central Drugs Standard Control Organization, there are 2,545 licensed blood-

banks up to November 2012, of which 1564(61.5%) were private blood banks and the

remaining 981(38.5%) are government blood banks (CDSCO, 2014). Currently, Department

of AIDS Control is supporting 1,137 blood banks across the country (2013-14) that increased

from 1,118 in 2012-13(NACO, 2014b).

Further analysis indicates that the country has 2.10 blood banks per one million populations

with a huge disparity across the

states. The high focus Non North-

East states1 that include, Bihar,

Madhya Pradesh, Chhattisgarh,

Odisha, Himachal Pradesh,

Rajasthan, Jammu & Kashmir, Uttar

Pradesh, Jharkhand and Uttarkhand

has the lowest number of blood

banks per 1,000,000 populations. As

indicated in Figure 5, there is a disparity among states, as well. BTS in India is fairly in the

advanced stage that is mainly concentrated in urban areas. BTS at sub-urban and rural areas

need improvement (Choudhury, 2011; Ramkishan et al., 2012). Though population size is a

key factor, areas with difficult terrain and other impediments of physical access need special

consideration while planning for blood banks.

1 High Focus - Non NE States: Bihar, Madhya Pradesh, Chhattisgarh, Odisha, Himachal Pradesh,

Rajasthan, Jammu & Kashmir, Uttar Pradesh, Jharkhand and Uttarakhand

Non High Focus – Large: Andhra Pradesh, Kerala, Goa, Maharashtra, Gujarat, Punjab, Haryana,

Tamil Nadu, Karnataka, West Bengal

High Focus – NE: Arunachal Pradesh, Manipur, Assam, Nagaland, Meghalaya, Tripura, Mizoram,

Sikkim

Non High Focus - Small & UT: Dadra & Nagar Haveli, Delhi, Chandigarh, Lakshadweep, Daman & Diu,

Puducherry, Andaman & Nicobar Islands

of 115

2.10

0.00

2.00

4.00

6.00

8.00

10.00

12.00Laksh

ad

we

ep

Bih

ar

Utt

ar

Pra

de

sh

We

st

Be

ngal

Raja

sth

an

Jhark

han

d

Man

ipu

r

Ch

hatt

ish

garh

Mad

hya P

rad

esh

Tri

pu

ra

Ori

ssa

Me

gh

ala

ya

Jam

mu

& K

ash

mir

Ind

ia

Assam

Utt

ara

kh

an

d

Gu

jara

t

Nagala

nd

Hary

an

a

Mah

ara

sh

tra

Go

a

Karn

ata

ka

Dad

ra a

nd

Nagar

Have

li

Him

ach

al P

rad

esh

An

dh

ra P

rad

esh

Pu

nja

b

De

lhi

Ch

an

dig

arh

Tam

il N

ad

u

Dam

an

an

d D

iu

Sik

kim

Aru

nach

al

Pra

de

sh

Ke

rala

An

dam

an

an

d N

ico

bar

Miz

ora

m

Pu

du

ch

err

y

Fig 5: Blood Banks per 1,000,000 population (one million)

34%

27%

39%

Fig 6:Type of Blood Collection 2012-13

( All reporting Units n: 2694 )

Voluntary Donation BBs Replacement Donation BBs

Voluntary Donation Camps

34%

17%

49%

Fig 7: Type of Blood Collection 2012-13

(DAC Supported n:1039)

Voluntary Donation in BBsReplacement Donation in BBsVoluntary Donation in Camps

Volume of Blood Units Collected

According to SIMS data(2012-13), the total units of blood collected in 2012-13 was

7,106,884 from all reporting units across the country, of which, 73% were from voluntary

donation (34% (2,394,363) from voluntary donation in blood banks, 39% (2,764,192) from

voluntary donation in camps and a significant 27%(1,948,329) was from replacement

donations in Blood banks (fig 6). The DAC supported blood banks recorded a higher

proportion of voluntary blood donation of 83% (fig 7). The Total blood units per 100,000

populations for the country were 587.3 units in 2012-13.

of 115

587.3

0

1000

2000

3000

4000

5000

6000

7000

8000

Bih

ar

Ch

hat

isga

rh

An

dam

an &

Nic

ob

ar

Jam

mu

& K

ash

mir

Utt

ar P

rad

esh

Me

ghal

aya

Aru

nac

hal

Pra

de

sh

Tam

il N

adu

Mah

aras

htr

a

Mad

hya

Pra

de

sh

Jhar

khan

d

Him

ach

al P

rad

esh

Nag

alan

d

Ori

ssa

Ass

am

Dam

an &

Diu

Man

ipu

r

Ind

ia

Sikk

im

Trip

ura

Raj

asth

an

An

dh

ra P

rad

esh

Kar

nat

aka

Utt

aran

chal

We

st B

en

gal

Har

yan

a

Ke

rala

Go

a

Gu

jara

t

Pu

nja

b

Miz

ora

m

Dad

ra &

Nag

ar H

ave

li

Po

nd

ich

err

y

De

lhi

Ch

and

igar

h

Fig 8: Total Blood Units per 100,000 population - State wise (All reporting Units)

The SIMS Data 2012-13 indicated that the Government Blood banks recorded around 49%

(3,487,571) of the total blood collection in the country followed by private (32.4% - 2,302,134)

and voluntary/charitable blood banks 18.5% (1,317,179).

Government

Blood Bank

49.1%Private

32.4%

Voluntary/Char

itable

18.5%

Fig 9 : Volume of Blood Collection based on Type of BBs

(All Reporting Units)

of 115

A greater proportion of blood collection was from private and voluntary/charitable blood

banks in states such as, Delhi, Karnataka, Uttaranchal, Haryana, Kerala, Jharkand, Tamil

Nadu and Gujarat.

4.2.4. The demand and supply

It is the responsibility of the state to ensure timely access to safe and sufficient supplies of

blood and blood products and good transfusion practices to meet the patients’ needs.

Ensuring universal access to safe blood and blood products and work towards self-

sufficiency in safe blood and blood products based on voluntary unpaid blood donation is

vital to achieving universal health coverage (WHO, 2013a). National requirements for blood

are, in part, determined by the capacity of the country’s health care system and its coverage

of the population (WHO, 2010c). In developed countries with advanced health systems, the

demand for blood continues to rise to support increasingly sophisticated medical and

surgical procedures, trauma care and the management of blood disorders. An increase in

ageing populations requiring more medical care has also led to increased requirements for

blood. According to WHO estimates, blood donation by 1% of the population is generally the

minimum needed to meet a nation’s most basic requirements for blood; the requirements

49.1

0.0

20.0

40.0

60.0

80.0

100.0

120.0

Dad

ra &

Nag

ar H

ave

li

Gu

jara

t

An

dh

ra P

rad

esh

Tam

il N

ad

u

Jhark

han

d

Ke

rala

Har

yan

a

Utt

ara

nch

al

Kar

nata

ka

De

lhi

Ind

ia

Pu

nja

b

Mah

ara

sh

tra

Raja

sth

an

Utt

ar

Pra

de

sh

Aru

nac

hal

Pra

de

sh

Po

nd

ich

err

y

Bih

ar

We

st

Be

ngal

Sik

kim

Assam

Mad

hya

Pra

de

sh

Miz

ora

m

Me

gh

ala

ya

Ch

an

dig

arh

Ori

ssa

Ch

hat

isgarh

Go

a

An

dam

an &

Nic

ob

ar

Isla

nd

s

Dam

an

& D

iu

Him

ach

al P

rad

esh

Jam

mu

& K

ash

mir

Man

ipu

r

Nag

ala

nd

Tri

pu

ra

Fig 10: % of Blood collection in Govt Blood Banks (statewise)

of 115

8443160 8312944

7106884

1000000

2000000

3000000

4000000

5000000

6000000

7000000

8000000

9000000

2010-11 2011-12 2012-13

Fig 11- Total Blood Units Collected

(SIMS, 2012-13-All Reporting Units)

are higher in countries with more advanced health care systems. As per WHO standards,

India’s demand for blood and blood components should be one percent of the total

population which is around 12 million blood units (1% of 1.2 billion populations). The annual

requirement of blood for the country is estimated at 80 lakh units of blood in 2012-13 by

the Department of AIDS Control (DAC, 2013).

However, there are several reports indicating different volume of blood units collected per

annum. In 2007, the reported collection of blood units in India was reported to be 4 million

against the need of 10 million (WHO, 2008c). In 2011, it was reported that Indian Blood

banks were able to 5.5 million blood units against the requirement of 9 to 9.5 million per

year which is a serious mismatch in the demand and availability(Kora S.A., 2011). Another

report says that India has 2,433 blood banks that can collect 9 million units of blood

annually, but collects only 7 million (Aggarwal S, 2012). The requirement of blood for the

country is estimated to be 85 lakh to 1 crore units/year, whereas the available supply is only

74 lakh units/year (Umakanth Siromani et al., 2013). According to the Central Drugs

Standard Control Organization (CDSCO), India has a total of 2545 licensed blood banks and

the annual blood collection was approximately 8.2 million units but requirement was close

to 10 million units leading to a shortage of 2 million blood units. Another report says that,

against an annual demand of 8,500,000 units/year, the availability of blood in government

supported blood banks is 4,400,000 units/year in 2009-10 and the remaining is reported to

be addressed through private hospital/private commercial blood banks (Bachani &

Sogarwal, 2010).

The recently launched National AIDS

Control program, Phase IV (NACP-IV)

sets an annual target of 9 million

blood units by 2017 through the

DAC supported blood banks.

According to SIMS data in 2013, the

total units of blood collected in

2012-13 were 7,106,884 that again indicate a shortage of 30%. It is also important to note

that the volume of blood collection is indicating a decreasing trend (around 16% decline

of 115

697.67686.91

587.3

200

300

400

500

600

700

800

2010 - 11 2011 - 12 2012 - 13

Fig 12 - Total Units per 100,000

population

(All Reporting Units)4646446 4640368

4204171

2000000

2500000

3000000

3500000

4000000

4500000

5000000

2010-11 2011-12 2012-13

Fig 13- Total Blood Units Collected

(DAC Supported n:1039)

from 2010-11 to 2012-13) both at the country level as well as in the DAC supported blood

banks and the reasons for the declining trend may be explored. Literature says that if 1-3%

of a country’s population donate blood, it would be sufficient for the country’s needs for a

year. Though there are several reports indicating different numbers, it is evident that India

faces a blood deficit of approximately 30-35 per cent annually. The SIMS data also indicated

that there is a decline in the total number of blood units collected over the years.

4.2.5. Transfusion Transmitted Infections

Transfusion transmitted infections (TTIs) are a major problem associated with blood

transfusion (Chandra, Rizvi, & Agarwal, 2014; Gupta, Singh, Singh, & Chugh, 2011). Accurate

estimates of the risk of TTIs are essential for monitoring the safety of blood supply and

evaluating the efficacy of the screening procedures. The major concern is due to the

prevalence of asymptomatic carriers and the donations during the window period of

infections. However, there have been active efforts to provide safe and quality blood and

blood products by improving the screening procedures world-wide. Screening for TTIs such

as, HIV 1, HIV 2, Hepatitis B, Hepatitis C, Malaria and Syphilis is mandatory in India. Because

of the active efforts, the prevalence of TTIs has come down significantly over the years.

of 115

The positivity of TTIs among the donors in the country over the years is depicted in Fig 12.

Though there is a decline in HIV and Hepatitis B positivity, a slightly increased positivity is

seen in HepC and VDRL but DAC supported blood banks reported a decline in all TTIs.

0.00

0.50

1.00

1.50

HIV Positivity Hep B Positivity HepC Positivity VDRL Positivity

0.22

1.08

0.350.200.20

1.04

0.360.210.19

0.98

0.390.22

Fig 14- TTIs Positivity (2010-11 to 2012-13)


2010-11 2011-12 2012-13

0.00

0.50

1.00

1.50

HIV Positivity Hep B Positivity HepC Positivity VDRL Positivity

0.25

1.18

0.340.220.22

1.12

0.330.210.20

1.05

0.340.20

Fig 15- TTIs Positivity (2010-11 to 2012-13)

(DAC Supported)

2010-11 2011-12 2012-13

0.19

0.000.050.100.150.200.250.300.350.400.450.50

An

dam

an

& N

ico

bar

Aru

na

ch

al P

rad

esh

Sik

kim

Jha

rkh

an

d

Dad

ra &

Nag

ar H

av

eli

Jam

mu

& K

ash

mir

Trip

ura

Ass

am

Ch

an

dig

arh

Utt

ara

nc

ha

l

Ke

rala

Go

a

Him

ach

al

Pra

de

sh

Ma

dh

ya P

rad

esh

Gu

jara

t

Po

nd

ich

err

y

Ori

ssa

Pu

nja

b

Raj

ast

ha

n

Ch

ha

tisg

arh

Utt

ar

Pra

de

sh

Ha

rya

na

Nag

ala

nd

Me

gh

ala

ya

Bih

ar

Ind

ia

Miz

ora

m

Ka

rna

tak

a

Ma

nip

ur

De

lhi

We

st B

en

gal

An

dh

ra P

rad

esh

Ma

har

ash

tra

Ta

mil

Nad

u

Dam

an &

Diu

Fig 16- HIV Positivity- Statewise 2012-13


of 115

Malaria positivity was found to be 0.04% in 2012-13. Though the majority of the states are

indicating lower HIV positivity levels comparing to the national positivity levels, the high

prevalence states like Karnataka, Manipur, Andhra Pradesh, Maharashtra and Tamil Nadu

are indicating higher positivity level than the national level. Similarly, around 16 states in the

country indicated a higher positivity level of Hep B comparing with the national average.

It is important to note that different types testing processes and methods with different

levels of sensitivity and specificity are in place across the institutions/states/country that

might influence the testing outcomes.

As proved earlier, the positivity among replacement donors is found to be relatively higher

that indicates the need for promoting voluntary donation.

0.250.20 0.19

0.28 0.27 0.25

0.00

0.10

0.20

0.30

2010-11 2011-12 2012-13

Fig 18- HIV Positivity

Voluntary Vs Replacement

(DAC supported)

HIV Positivity Voluntary HIV Positivity Replacement

0.220.19 0.17

0.23 0.220.25

0.00

0.20

0.40

2010-11 2011-12 2012-13

Fig 17- HIV Positivity

Voluntary Vs Replacement donors


HIV Positivity Voluntary

HIV Positivity Replacement

0.98

0.00

0.50

1.00

1.50

2.00

2.50

Ke

rala

Him

ach

al P

rad

esh

Jam

mu

& K

ash

mir

Assa

m

Go

a

Na

ga

lan

d

Sik

kim

Jha

rkh

an

d

Ch

an

dig

arh

Gu

jara

t

Ori

ssa

Ch

ha

tisg

arh

Pu

nja

b

Me

gh

ala

ya

Ma

nip

ur

Utt

ara

nch

al

Tri

pu

ra

Ka

rna

taka

Ind

ia

Ha

rya

na

Utt

ar

Pra

de

sh

We

st

Be

ng

al

Ta

mil

Na

du

Aru

na

ch

al …

Miz

ora

m

De

lhi

An

dh

ra P

rad

esh

Ra

jasth

an

Ma

ha

rash

tra

Ma

dh

ya

Pra

de

sh

Da

ma

n &

Diu

Bih

ar

Po

nd

ich

err

y

Da

dra

& N

ag

ar …

Fig 19 - Hep B Positivity-Statewise 2012-13(All Reporting Units)

of 115

In terms of Hepatitis C, States like, Punjab(1.09%), Mizoram(1.01%), Manipur(0.92%),

Haryana(0.85%), Uttaranchal(0.65%), West Bengal(0.65%), Delhi(0.63%), Tamil Nadu(0.48%,

UP(0.43%), Chandigarh(0.41%) and Maharashtra(0.40%) have recorded higher positivity

level than the national average of 0.39 percent.

0.39

1.09

0.000.200.400.600.801.001.20

An

dam

an

&…

Tri

pu

ra

Da

dra &

Nag

ar…

Jh

ark

ha

nd

Ori

ssa

Da

man

& D

iu

Go

a

Aru

nac

ha

l…

Him

ach

al P

rad

esh

Ma

dh

ya

Pra

de

sh

Assa

m

Ja

mm

u &

…

Sik

kim

Po

nd

ich

erry

Nag

ala

nd

Ch

ha

tisg

arh

Gu

jara

t

Raja

sth

an

Ka

rn

ata

ka

Bih

ar

Ke

rala

An

dh

ra

Pra

de

sh

Me

gh

ala

ya

Ind

ia

Ma

ha

ra

sh

tra

Ch

an

dig

arh

Utta

r P

ra

de

sh

Ta

mil

Na

du

De

lhi

We

st B

en

gal

Utta

ran

ch

al

Ha

ry

an

a

Ma

nip

ur

Miz

ora

m

Pu

nja

b

Fig 22- HepC Positivity-Statewise 2012-13 (All Reporting Units)

1.06 1.01 0.951.14 1.13 1.06

0.00

0.50

1.00

1.50

2010-11 2011-12 2012-13

Fig 20 -HepB Positivity

Voluntary vs Replacement


Hep B Positivity Voluntary Hep B Positivity Replacement

1.12 1.06 1.00

1.40 1.36 1.29

0.00

0.50

1.00

1.50

2010-11 2011-12 2012-13

Fig 21- HepB Positivity

Voluntary vs Replacement

(DAC Supported)

Hep B Positiv ity Voluntary

Hep B Positiv ity Replacement

of 115

0.22

0.000.200.400.600.801.001.201.40

Dadra & Nagar Haveli

Mizoram

Manipur

Kerala

Pondicherry

Tripura

Chandigarh

Jharkhand

Karnataka

Bihar

Maharashtra

Goa

Andhra Pradesh

Uttar Pradesh

Orissa

Nagaland

Himachal Pradesh

Sikkim

Gujarat

Uttaranchal

India

Assam

Daman & Diu

Haryana

Andaman & Nicobar

Rajasthan

West Bengal

Jammu & Kashmir

Delhi

Madhya Pradesh

Tamil Nadu

Chhatisgarh

Punjab

Meghalaya

Arunachal Pradesh

Fig 23-VDRL Positivity 2012-13 - Statewise(All Reporting Units)

All TTI infections such as HIV, Hep B, Hep C and VDRL are indicating higher positivity among

replacement donors.

0.00

0.20

0.40

0.60

2010-11 2011-12 2012-13

0.33 0.33 0.330.42 0.43 0.42

Fig 24- Hep C Positivity



Hep C Positivity Replacement Hep C Positivity

0.18 0.18 0.18

0.25 0.27 0.25

0.00

0.10

0.20

0.30

2010-11 2011-12 2012-13

Fig 25-VDRL Positivity


(ALL Reporting Units)

VDRL Positivity Voluntary VDRL Positivity Replacement

0.04

0.00

0.10

0.20

0.30

0.40

0.50

Ch

an

dig

arh

Da

dra

& N

ag

ar…

Goa

Man

ipur

Miz

ora

m

Tri

pu

ra

Pu

nja

b

Him

ach

al P

rad

esh

Ka

rna

tak

a

We

st B

en

ga

l

Po

nd

ich

err

y

Ha

ryan

a

Ch

hati

sga

rh

Ma

ha

rash

tra

Ra

jast

han

Utt

ara

nch

al

Ke

rala

De

lhi

Guja

rat

Ma

dh

ya

Pra

de

sh

Sik

kim

Ind

ia

An

dh

ra P

rad

es

h

Me

gh

ala

ya

Bih

ar

Ori

ssa

Utt

ar

Pra

de

sh

Da

ma

n &

Diu

Ass

am

Jam

mu

& K

ash

mir

Jhark

ha

nd

Aru

na

ch

al P

rad

esh

An

da

ma

n &

…

Ta

mil

Na

du

Nag

ala

nd

Fig 26: Malaria Positivity 2012-13


of 115

4.2.6. Blood Transfusion Services Components under National AIDS Control

Programme – A Review

India gave utmost importance to Blood safety since the beginning of HIV epidemic that can

be understood from the fact that, in 1986, the Indian Council of Medical Research (ICMR) in

collaboration with the Directorate General of Health Services (DGHS) and individual State

Governments initiated a national programme of serological surveillance (ICMR, 1987). They

had also initiated blood safety and AIDS case management programmes whereby existing

medical colleges and institutes had been designated as regional centres for the clinical

treatment of AIDS that paved the way for the creation of National AIDS Control Organization

in 1992 for coordinating a broader range of AIDS-related Programme and policies.

After that, recognizing the urgency of improving blood safety in India, the first phase of the

NACP (1992-99) focused on screening all blood units collected for blood transfusions and

decrease the practice of professional blood donations. NACO has undertaken initiatives to

improve testing of blood and blood products, strengthen existing government facilities and

external quality control, promote voluntary blood donation, develop and improve facilities

for plasma fractionation, and to improve the management, monitoring and evaluation of

blood transfusion services.

The second phase (1999-2007) focused on scaling up the services carried out in phase I. The

NACP II also focused on quality management systems (EQAS for HIV testing, Accreditation),

strengthening capacity building initiatives, and appropriate clinical use of blood and

promotion of voluntary non remunerated blood donation.

The third phase of the National AIDS Control Programme III (2007-12) aimed to ensure the

provision of safe and quality blood to the remote areas of the country in the shortest

possible time through a well-coordinated National Blood Transfusion Service(NACO, 2007g).

This was planned to be achieved by, Strengthening infrastructural facilities and establishing

blood storage centers in the primary health care system for availability of blood in remote

areas; ensuring that regular (repeat) voluntary non-remunerated blood donors constitute

the main source of blood supply; promoting appropriate use of blood, blood components

and blood products; developing long-term policy for capacity building to achieve efficient

and self-sufficient blood transfusion services; mandatory testing of each unit of blood for

of 115

HIV, Hepatitis B and C, Syphilis and Malaria and voluntary blood donation for which camps

are organized with the help of various organizations.

This section of review of blood transfusion services will be based on the broad components

that the National AIDS Control Programme envisaged over the years, that are,

i. Augmentation of Voluntary Blood Donation

ii. Access to safe and quality blood

iii. Appropriate Use of Blood and Blood Products - Clinical use of Blood and Blood

products

iv. Quality Assurance in Blood Transfusion Services

Hemovigilance

v. Monitoring and Evaluation System of Blood Transfusion Services in India

vi. Efficient Supply Chain Management and Quality Assurance

vii. Convergence with NRHM, other departments and Ministries

viii. Legal, regulatory and Policy Issues

ix. Ethical Issues of Blood Transfusion

4.2.6. (i). Augmentation of Voluntary Blood Donation (VBD)

It has been recognized world over that collection of blood from regular (repeat) voluntary

non remunerated blood donors should constitute the main source of blood supply, as

Voluntary non-remunerated donation has been shown to be the cornerstone of a safe and

sufficient blood supply and is the first line of defense against the transmission of infectious

diseases through transfusion(WHO, 2010c). Besides, meeting the transfusion requirements

through replacement donation by the family and friends are rarely able to meet the

demands for blood and paid commercial donation poses serious threats to the health and

safety of the recipients, as well as the donors themselves. In 2010, the World Health

Assembly defined self-sufficiency in the supply of safe blood and blood products based on

Voluntary Non-Remunerated Donation (VNRD), and the security of that supply, as important

national goals to prevent blood shortages and meet the transfusion requirements of the

patient population (WHO, 2013b). The resolution WHA63.12 urged Member States "to take

all necessary steps to establish, implement and support nationally-coordinated,

efficiently-managed and sustainable blood and plasma programmes according to the

of 115

availability of resources, with the aim of achieving self-sufficiency" (WHO, 2010d). There

were major blood system reforms in many countries to secure national blood supplies

through voluntary, non-remunerated donation and self-sufficiency in meeting national

blood needs (WHO, 2013b).

In 2011, the median donation rate was 39.2 donations/1000 population in high-income

countries, 12.6 in middle-income countries, and 4.0 in low-income countries. Especially,

some developed countries such

as Switzerland and Japan, the

number of voluntary blood

donors per 1,000 population

was reported to be 113 and 70

respectively, but in India it was

still very low, 8 for every 1,000

population (Agarwal, 2012).

The DAC supported blood banks indicated a significant increase in voluntary blood donation,

from 54.4% in 2007 to 83.4% in 2012 (NACO, 2013). Promotion of voluntary blood donation

has also enabled reducing transmission of HIV infection through contaminated blood from

about 6.07% in 1999 to 0.2% in 2012. However, according to SIMS data, the VBD status for

the entire country showed a plateau trend from 2010-11 to 2012-13(Figure 28). Out of the

total units of blood collected from both blood banks and camps, 72.6% was from voluntary

donation. However, there is a disparity in the proportion of voluntary donation across

states. (Fig-9)

Source: NACO Annual Report 2012-13

71.31 72.91 72.5979.18 81.09 82.41

40

60

80

100

2010-11 2011-12 2012-13

Fig 28 - % of Voluntary Blood Donation - (SIMS)

(All Reporting Units Vs DAC Supported)

% VBD -All Reporting Units % VBD -DAC Supported

of 115

72.59

0102030405060708090

100U

ttar

Pra

de

sh

Man

ipu

r

De

lhi

Me

gh

ala

ya

Hary

an

a

Assam

Bih

ar

Pu

nja

b

Karn

ata

ka

Jhark

han

d

Ch

hati

sgarh

Ori

ssa

Him

ach

al P

rad

esh

Ind

ia

Po

nd

ich

err

y

An

dh

ra P

rad

esh

An

dam

an

& …

Aru

nach

al

Pra

de

sh

Jam

mu

& K

ash

mir

Mad

hya P

rad

esh

Nagala

nd

Raja

sth

an

Gu

jara

t

Ke

rala

Go

a

Utt

ara

nch

al

Sik

kim

We

st

Be

ngal

Ch

an

dig

arh

Mah

ara

sh

tra

Tam

il N

ad

u

Tri

pu

ra

Miz

ora

m

Dam

an

& D

iu

Dad

ra &

Nagar

…

Fig 29: Statewise proportion of VBD (2012-13) -

(All reporting Units)

UP, Manipur, Delhi, Meghalaya, Haryana, Karnataka, Assam, Bihar, Punjab, and Jharkhand.

Chhattisgarh, Orissa, HP were the states that recorded lower level of VBD than the national

average. Maharashtra, Tripura, Tamil Nadu, Mizoram, Daman and Die, Dadra Nagar Haveli

recorded more than 90% VBD.

According to the SIMS data for the entire country, majority of blood donation was from the

male (93%) that is corroborating with the World Health Organization’s (WHO) global

database on blood safety updated in June 2011 that reported mind-boggling gender

disparity among blood donors that was 94 percent of blood donations in the county by

men. However, a higher proportion of the female population voluntarily donated blood

through camps. Only 2% of total replacement donation was from females.

82.41

0

20

40

60

80

100

Ma

nip

ur

Me

gh

ala

ya

De

lhi

As

sam

Utt

ar

Pra

de

sh

Ch

hat

isg

arh

Him

ach

al P

rad

esh

Ori

ssa

Kar

na

tak

a

An

dam

an

& …

Bih

ar

Aru

na

chal

Pra

de

sh

Jam

mu

& K

ash

mir

Jha

rkh

and

Nag

ala

nd

Ind

ia

Pu

nja

b

Utt

ara

nc

ha

l

Raj

asth

an

Sik

kim

Go

a

Po

nd

ich

err

y

We

st

Be

nga

l

Ch

an

dig

arh

Ke

rala

Gu

jara

t

Har

yan

a

An

dh

ra P

rad

es

h

Mad

hy

a P

rad

esh

Tri

pu

ra

Miz

ora

m

Ma

ha

ras

htr

a

Tam

il N

ad

u

Da

ma

n &

Diu

Da

dra

& N

aga

r …

Fig 30- State wise proportion of VBD 2012-13

(DAC Supported)

of 115

90%

10%

Fig 33 : VBD in Camps - Gender


VBD Male - Camps VBD Female - Camps

90%

10%

Fig 34- VBD in Camps - Gender

(DAC Supported)

VBD Male - Camps

VBD Female - Camps

97%

3%

Fig 31: VBD in BBs - Gender


VBD Male - BB VBD Female-BB

98%

2%

Fig 32: VBD in BBs - Gender

(DAC Supported)

VBD Male - BB VBD Female-BB

Blood donation camps play a major role in the Blood transfusion services in India. Figures 35

and 36 clearly indicate that a significant proportion (35 to 38%) of blood collection in the

country is from camps. The proportion is higher among DAC supported blood banks.

of 115

4646446 46403684204171

2058177(44.2%) 2189971(47.19%) 2045784(48.66%)

0

1000000

2000000

3000000

4000000

5000000

2010-11 2011-12 2012-13

Fig 36: Total Blood Units Vs VBD from Camps

(DAC Supported)

Total Blood Units VBD from Camps

6244766757

60872

25000

35000

45000

55000

65000

75000

2010-11 2011-12 2012-13

Fig 37: Number of Blood donation Camps


4397946356 46687

18468 20401

14185

0

10000

20000

30000

40000

50000

2010-11 2011-12 2012-13

Fig 38: Blood Donation Camps

(DAC supported and Others)

Blood Donation Camps- DAC Supported Blood Donation Camps- Others

According to SIMS, the number of camps conducted during the 2012-13 was 60,872, out of

which, 46687 (76.6%) were by DAC supported blood banks.

of 115

786,656839,403 840,466

300000

400000

500000

600000

700000

800000

900000

2010-11 2011-12 2012-13

Fig 39: Repeat Donation

(All Reporting Units )

481488506647

536204

300000

350000

400000

450000

500000

550000

2010-11 2011-12 2012-13

Fig 40: Repeat Donation

(DAC Supported)

The number of camps conducted during 2012-13 decreased from 2011-12, however, that is

primarily due to the reduction in the number of camps conducted by non DAC supported

blood banks.

Repeat Voluntary Blood Donation

Voluntary non-remunerated repeat blood donors are perceived to be safer than the first

time blood donors (Choudhury et al., 2011). By improving the repeat voluntary donors, the

reliability of blood supply and safety of blood and blood products can be assured (WHO,

2012a). Literature suggests that the repeat donors, irrespective of family, replacement or

volunteer non-remunerated donors are considered as the most viable alternative to ensure

safe blood (Allain, 2011; Tagny, 2012).

The SIMS data indicated an increasing trend in repeat donation in the country and the

proportion of repeat donation out of total voluntary donation (blood banks and Camps)

showed an increasing trend from 13 percent in 2010-11 to 16.3 percent in 2012-13.

However the current level is low when comparing with countries like Iran that achieved

75.2% of its donation through regular and repeat donors in 2012(IBTO, 2013). The DAC

supported blood banks also indicated a similar proportion of repeat donations comparing

with total voluntary donation (13.1; 13.5 and 15.5% from 2010-11 to 2012-13). So, it is

important to increase donation rates among the younger generation, increase the number

of repeat donors and to secure wider community support for blood donation.

of 115

4.2.6. (ii). Access to safe and Quality Blood

The availability and accessibility of safe blood and blood products are vital for the

prevention of HIV infection and to the achievement of the health-related Millennium

Development Goals to reduce child mortality, improve maternal health, combat HIV and

other infections (WHO, 2008b). However, access to safe and effective blood products is a

major challenge in low and middle income countries like India due to various reasons such

as lack of basic facilities and systems, low quality and safety standards need to be

established or strengthened, and insufficient supply.

In India, access to safe blood is mandated by law (NACO, 2014a) and it is the primary

responsibility of the government (WHO, 2002). The blood safety programme in India aims to

make available safe and quality blood within one hour of requirement in a health facility

(NACO, 2014a). Over the years, access to safe and quality blood has increased significantly

due several factors such as, increased number of blood banks, increased voluntary blood

donation, appropriate use of blood and products, reduction in wastages, increased quality,

improved infrastructure and service delivery. Nevertheless, the need for blood continues to

grow due to, changes in population demographics and disease patterns, expansion and

development of health systems, improvements in diagnostic and treatment options and

advances in surgical and medical procedures requiring blood transfusion(WHO, 2013c).

13.1 13.5

15.5

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

2010-11 2011-12 2012-13

Fig 41: Repeat Donation as proportion of Total

Voluntary Blood Donation (BBs and Camps)

(DAC supported)

of 115

According to Department of AIDS Control, the availability of safe blood increased from 44

lakh units in 2007 to 93 lakh units by 2012(NACO, 2013). The gradual increase of the number

of blood banks, Blood Component Separation Units (BCSUs) and blood storage centres (BSC)

in the country has indeed increased the access to blood and blood products. However, as

per World Health Organization (WHO) guidelines, there is 31 percent deficit of available

blood at national level; in rural areas this proportion is much higher in India (Pandey, 2014).

The safety of blood and blood products are ensured through the following,

• Department of AIDS Control provides all test kits to all the government and

charitable blood banks like Red Cross;

• The Drugs & Cosmetics Act provides a legal framework under which the blood banks

are inspected and issued a proper license

• The blood banks are jointly inspected by the Drug Inspectors of the Food and Drug

Administration and by the SACS of the respective states

• Blood safety training program by DAC to ensure an uniform training curriculum for

all aspects of blood transfusion. This will impart training on all aspects of blood

safety involving Blood Bank Medical Officers, Technicians, Counselors, Nurses,

clinicians, donor Motivators and Programme Officers of SACS through 17 centers

identified across the country. Voluntary blood donation trainings were held in four

regions to augment voluntary blood donation in the country.

But there are still gaps; and lack of access to safe blood still remains a major cause of

maternal mortality in all parts of the country (Vora et al., 2009).

of 115

The lack of access to safe blood services due to both supply side and demand side factors is

given in (Table 2).

Table 2. Factors contributing to Lack of access to safe blood and blood products in India

Supply Side Factors Demand Side factors

• Shortage of blood supply

• Skewed distribution of service delivery

units such as blood banks, BSUs.

• Stock-out of test kits and reagents

• Minimal Infrastructure (Ramani et al.,

2009)

• Obsolete equipment

• Insufficient and Lack of trained human

resources

• Poor supply chain management system,

• Lack of cold chain transportation

• Huge costs in carrying blood from

remote banks

• In appropriate use of blood and blood

products,

• Quality Management System

• Lack of institutional coordination and

coordination between health systems.

• Unclear roles and responsibilities

between structures.

• Poor as socio-economic and cultural

factors.

• Lack of awareness, knowledge, myths

and misconception

• Poor physical access to service delivery

points such as blood banks. Poor

availability of transportation, long

distance.

• User Fee (Processing Fee)

• Lack of free availability of components.

All these factors, in fact, lead to lack of and inequitable access to blood and blood products

in the country. Especially, the shortages also contribute to increased risk of infection

transmission by forcing a reliance on unsafe replacement or paid donors and greater

pressure to issue untested blood (WHO, 2008a)

4.2.6. (iii). Quality Assurance in Blood Transfusion Services

The quality systems in Blood Transfusion Services cover the entire transfusion process, from

donor recruitment to the follow-up of the recipients of transfusion (CDC, 2011), which

requires the establishment of well-organized, nationally-coordinated blood transfusion

services to ensure the timely availability of safe blood and blood products for all those who

require transfusion services (WHO, 2008c). The Quality Assurance includes the collection of

blood from voluntary unpaid blood donors from low-risk populations to quality-assured

testing for transfusion-transmissible infections, blood grouping and compatibility testing.

of 115

The overall aim is to promote safe and appropriate use of blood and to reduce unnecessary

transfusions (CDC, 2011).

Over the years a fragmented mix of competing independent and hospital-based blood-banks

of different levels of sophistication, different level of quality levels, serving different types of

hospitals and patients have emerged in India (Ramani et al., 2009). The population explosion

and the expansion of poorly regulated health care market propagate this fragmented

evolution in blood banking with different quality levels. Nevertheless, assured quality

services in blood storage and transfusion services are extremely important in transfusion

services.

In order to these concerns of Quality Assurance, the Quality Management Project (QMP)

has been implemented in all the WHO regions since 2001 that aims to introduce and

strengthen the quality aspects of Blood Transfusion Services (BTS) with the objective to

improve the safety, adequacy and quality of blood. In India, the National Quality

Management Training Course was conducted in October 2001 where the State Program

Officers were sensitized regarding QMP and its utility to assure quality, safety and adequacy

of blood(Pal et al., 2011). The Department of AIDS Control in India emphasize certain

practices such as, licensing of blood storage and transfusion facilities, supervisory visits,

Internal Quality Control Procedures and the External Quality Assessment Schemes

(EQAS)/Proficiency Testing to ensure quality of the BTS at all levels. The DAC also developed

and disseminated a “Manual on quality standards for HIV Testing laboratories” for

practicing quality assurance required for HIV testing on a day today basis, training,

implementation of quality assurance programmes in all the HIV testing facilities including

blood banks across the country (NACO, 2007c)

a. Licensing of blood storage and transfusion facilities

The first step of quality assurance is ensured through mandatory licensing of all the blood

storage and transfusion facilities in the country which need to be obtained from the

State/Union Territory licensing authority after satisfying the conditions and facilities through

inspection. The approval is valid up to a period of five years from the date of issue unless

sooner suspended or cancelled. An application for renewal is to be made three months

prior to the date of expiry of the approval. Even in case of FRUs/ CHCs/ PHCs before

of 115

applying for the approval, the storage centre have to identify and obtain consent from the

blood bank from where they will get the supply of blood/blood components(GOI, 2001).

These could be licensed blood banks run by Government Hospitals/Indian Red

Cross/Regional Blood Transfusion Centres only. In case the license of the parent blood

bank/centre is cancelled, the license of the storage centre is also automatically cancelled.

The storage centres, can however, get affiliated to more than one blood bank/centre to

ensure un-interrupted supplies, but a separate approval is required in each case

b. Supervisory Visits to DAC- supported Blood Banks

A team in every State that comprises of four members namely one Blood Safety Official of

SACS, director of State Blood Transfusion Council (SBTC), one nominated expert in the field

of Transfusion Medicine and a member of State drug control, carries out the inspection of

all blood banks and voluntary blood donation camps (NACO, 2013). The team makes

periodic supervisory visits to and prepares reports identifying various constraints and the

methods to rectify them. Officers of DAC also undertake supervisory visits to blood banks in

various States.

c. Internal Quality Control Procedures

Internal Quality Control (IQC) consists of a set of procedures that are undertaken by the

staff for continuous and concurrent assessment of laboratory work and emergent results

(Jain, Sharma, & Gupta, 2013) (Bharucha et al., 2006). It facilitates the professionals to

check their own performance and to help them monitor the reliability of their techniques. In

India, the internal quality control is maintained in blood banks by going through a complete

checklist of items or tests daily to make sure that all systems are being monitored and in

control. Immediate decisions are also taken to accept or reject results/ products on daily

basis.

d. External Quality Assessment Scheme (EQAS) (NACO, 2013)

One of the most important aspects of accreditation is to continue checking performance by

way of participation in External Quality Assessment Schemes (EQAS)/Proficiency Testing

which provides an opportunity to any blood bank to compare its results with other blood

banks. It ensures that the blood bank is not only selecting the right method but also

following it properly. The department of AIDS Control in 1999 initiated the External Quality

of 115

Assessment Scheme (EQAS) for HIV testing for the Blood Banks and laboratories with the

objective of bringing qualitative improvement in the Blood banks and laboratories for HIV

testing. The programme has emphasized on quality practices and documentation of EQAS.

The National External Quality Assurance Scheme (NEQAS) for HIV has categorized the

laboratories in the country into four tiers as follows(NACO, 2013),

1. Apex laboratory (first tier) - National AIDS Research Institute, Pune,

2. Thirteen National Reference Laboratories (NRLs) located in all parts of India undertake

EQAS in their respective geographical areas including apex (second tier).

3. State level: 117 State Reference Laboratories (SRLs) (third tier)

4. Districts level, i.e., all ICTC & Blood banks (fourth tier).

Each NRL has been allotted specific states. The NRL mentors SRLs under them; and the SRL

in turn, monitor and mentors the ICTCs and blood banks under them. Sera panels are

distributed to the linked blood banks by the SRLs biannually.

Training of all the four tiers has been conducted. Blood Bank Medical Officers and

Technicians of around 1200 Blood Banks have also been trained in the country(NACO, 2013).

e. Accreditation

In order to ensure quality assurance in Blood Transfusion Services, DAC has been pursuing

the task of accreditation of blood banks through the National Blood Transfusion Council

(NBTC). In order to get NABH accreditation, all lab testing done in the Blood banks (including

TTIs and Immunohematology) should be covered under a formal EQA programme.

4.2.6. (iv). Monitoring and Evaluation System of Blood Transfusion Services in India

The National AIDS Control Programme established “one nationwide monitoring and

evaluation framework" under the "Three Ones” principle which ensures effective use of

information generated by government agencies, NGOs, CBOs, private and development

partners. The data generation originates from service delivery level to district, state and

national level. Currently, there are around 12,000 reporting units that include blood banks

across the country. The data flow for collecting data involves multiple points where data

of 115

quality is verified and further improved by State and National Strategic Information

management Units (SIMU).

The monitoring and evaluation of Blood banks are through the information generated from

Strategic Information Management System (SIMS). The establishment of Strategic

Information Management Units (SIMU) at the state and national level intensified the efforts

on improving data quality at all levels and brought together Monitoring and Evaluation,

surveillance, and operations research. Clear roles and responsibilities, validation (using a

validation checklist) and feedback at different levels, have ensured overall data quality. The

SIMS has sections of data collection that are, volume and profile of blood donors; results of

testing and separation; infrastructure and inventory management; storage unit linkages to

blood banks (NACO, 2007e). At state level, reports are compiled by the 5th

of every month,

and feedback is given to the regional health officers by the 15th of every month. At the start

of each year, monthly analysis of blood collection of the previous year is done to formulate

strategies to compensate for the deficit in blood collection in a particular month (Ramani et

al., 2009).

Supervision

At the District Level, the existing District Nodal Officer in charge of AIDS Control Programme

in the district visits each and every blood donation camp organized in the district to ensure

effective coordination. A monthly review of the implementation of blood bank using a

check-list is also undertaken. At the state level, SACS officials such as Joint Director (Blood

Safety) or Dy. Director (Blood Safety); Drug Inspector (FDA); SBTC official and an external

technical expert develop a joint supervisory plan and undertake periodic supervisory visits

to the blood banks in the state to assess the functional status, identify the constraints and

methods to rectify them. At the National Level, a threefold supervision framework exists

that includes the blood safety division at DAC; National Blood Transfusion Council (NBTC)

and Technical Resource Group (TRG) on Blood Safety. Based on the performance, the states

are categorized into, poor performing; Average performing; and Better performing states as

per laid down indicators. The poor performing states are visited by the

Consultant/Technical Expert once in a quarter, while other states will be randomly selected

for supervisory visit. Officers of DAC also undertake supervisory visits to blood banks in

of 115

various States to review the status. Members of NBTC as well as members of TRG are

assigned one state to give feedback to Department of AIDS Control on the overview of Blood

Transfusion Services twice a year.

4.2.6. (v). Appropriate Use of Blood and Blood Products – Clinical use of Blood and

Blood products

WHO recommends for the safe and rational use of blood to reduce unnecessary and unsafe

transfusions and to improve patient outcomes and safety, thus minimizing the risk of

adverse events including errors, transfusion reactions and transmission of infections (WHO,

2009a, 2014b). It is also suggested that blood and blood components should be

administered only when clinically indicated at the lowest effective dose and frequency.

Safer alternatives should always be used first whenever possible(MOH, 2009). Rational or

appropriate use of blood means providing the right blood product, in the right quantity, for

the right patient (WHO, 2002). It can help in bridging the gap between demand and supply

of the precious blood or blood products. Patients who require blood or blood products,

whether in life-threatening acute situations or as a supportive therapy in chronic

hematological disorders, must receive the required components only (WHO, 2006). The

safety, adequacy and effectiveness of blood supply can only be achieved if there are no

unnecessary transfusions.

Strategies ensuring rational use of blood includes, Developing guidelines and dissemination

at various levels; organizing clinical awareness training programmes; Setting up hospital

transfusion committees (HTC) to promote strategies for rational use of blood; Promoting

blood component therapy; Encouraging autologous transfusions and managing inventory of

blood in order to avoid wastage and transfusion of untested or improperly screened blood

(Bharucha et al., 2006).

In India, it is reported that the inappropriate use of blood is very common as single-unit

transfusion is often given which is not very much useful. Many a times, transfusion of blood

and blood products happen even there are safer alternative therapies(Kaur, Basu, Kaur, &

Kaur, 2013). With no monitoring system in place, it is found to be difficult to ensure the

rational use of blood as the use of blood in hospitals is hardly audited in India. WHO

of 115

recommends that the ratio of the use of blood components and whole blood should be

90:10 since only a limited category of clinical interventions require whole blood. The use of

blood-component therapy allows four patients to benefit from one unit of blood

collected(Ramani et al., 2009). In India, 80 percent of blood is used as whole blood, only and

20 per cent units are utilized as components (NACO, 2007a). Choudhury (2011) reported

that about 37% blood units are separated into components, and all collected units are

tested for five transfusion-associated infections as on record. It was also reported that

demand for components are not very high due to lack of awareness(Choudhury, 2011).

Though the Clinical use of blood is widely discussed in India, majority of blood banks collect

and stock whole blood. Licensing requirements do not have mandates to suggest the blood

banks to process the blood it collects into components or for institutions to introduce blood-

use audits. India is continuing to request for single units of fresh whole blood, ignoring the

fact that fresh blood is much more likely to transmit infection (Nanu, 2001). It is reported

that around 30% of the blood units are wasted or inappropriately used in India (Gupte,

2002). Drugs and Cosmetics Act 1940 and Rules 1946 which forbids the transfer of blood

from one bank to other under ordinary circumstances that really prevents the transfer of

blood and blood products to high volume blood banks to other places in need of it.

However, Department of AIDS Control reports that the practice of appropriate clinical use of

blood amongst the clinicians has seen a definite rise due to the dengue epidemic, and

training of clinicians on the rational use of blood (NACO, 2013). Blood Component

Separation Units are being started and started working in their respective States, and the

proportion of blood units processed for component separation has increased. Quality

management modules were also prepared by Technical Resource Group to increase Blood

Component separation in the BCSUs. A national guidelines on appropriate use of blood and

blood products has been prepared and circulated (Gupte, 2002). Besides, Medical Council of

India has made it mandatory that all Medical Colleges with post graduate training

programme should possess a blood separation facility.

According to SIMS data, though whole blood and its components are prepared, the

utilization per annum (supplied in the year is considered as utilization in this report) per

annum indicates lower levels. For examples, utilization of platelets over three years is

of 115

97.3 95.6 96.3

60.0

70.0

80.0

90.0

100.0

2700000

2800000

2900000

3000000

3100000

3200000

2010-11 2011-12 2012-13

Fig 42: Packed Cells Prepared and

Supplied %


Packed Cells Packed Cells Utlization

97.1 98.1 98.8

60.0

80.0

100.0

120.0

1300000

1400000

1500000

1600000

2010-11 2011-12 2012-13

Fig 43: Packed Cells Prepared and

Supplied %

(DAC Supported)

Packed cells Prepared Packed Cells Supplied

84.477.1 74.8

30.0

50.0

70.0

90.0

1500000

1550000

1600000

1650000

1700000

2010-11 2011-12 2012-13

Fig 44 : Platelets Prepared and Supplied %


Platelets Utilization

83.176.6 72.6

30.0

50.0

70.0

90.0

200000

700000

1200000

2010-11 2011-12 2012-13

Fig 45: Platelets Prepared and Supplied %

(DAC Supported)

Platelets Utlization

around 75 to 85%; fresh frozen plasma utilization is around 65 to 75% during the last three

years. It is essential to develop and establish a systematic approach and operational

guidelines to assess and ensure quality and quantity of blood components prepared across

the country. Strategies also need to be planned to maximize the utilization rates of blood

and blood components.

72.8 72.166.3

30.0

50.0

70.0

90.0

0

500000

1000000

1500000

2010-11 2011-12 2012-13

Fig 47 Fresh Frozen Plasma prepared and

Supplied %

(DAC Supported)

Fresh Frozen Plasma Utlization

69.6 68.864.5

30.0

40.0

50.0

60.0

70.0

80.0

2400000

2500000

2600000

2700000

2800000

2900000

2010-11 2011-12 2012-13

Fig 46: Fresh Frozen Plasma prepared

and Supplied %


Freshfrozen Plasma Freshfrozen Plasma Utlization

of 115

Haemovigilance

Monitoring clinical use of blood and blood products in India is weak, and there is no

systematic analysis to measure adverse reactions following blood transfusion. Besides,

Blood-banks lack registering or monitoring of total demand for blood and blood products for

each blood group that could not be met due to the non-availability of blood or blood

products. They do not report systematically the proportion of stored blood that expired due

to non-use as well. This calls for Haemovigilance system which is required to identify and

prevent occurrence or recurrence of transfusion related undesirable events, increase the

safety, efficacy and efficiency of blood transfusion, covering all activities of the transfusion

chain from donor to recipient (WHO, 2014a). The system includes monitoring, identification,

reporting, investigation and analysis of adverse events including, reactions related to

transfusion and manufacturing. These systems are designed in a way that it will define

problems encountered in the entire chain of the transfusion process which in turn will

facilitate to direct the efforts and resources appropriately; ensure that the endpoint of a

safe and effective transfusion is achieved; and enable to collect, interpret and use

information on the long and short term effects of transfusion.

71.474.7

71.0

30.0

40.0

50.0

60.0

70.0

80.0

115000

120000

125000

130000

135000

2010-11 2011-12 2012-13

Fig 48 : Cryoprecipitate Prepared and Supplied


Cryoprecipitate Cryoprecipitate Utilization

of 115

Haemovigilance in India

The centralised Haemovigilance programme in India to assure patient safety and to promote

public health, was lunched on 10th December, 2012 in 90 Medical Colleges along with a

well-structured program for monitoring adverse reactions associated with blood transfusion

and blood product administration. This program is being implemented under overall ambit

of Pharmacovigilance Program of India (PvPI), coordinated by Indian Pharmacopoeia

Commission (IPC). Currently there are 142 Centers under Haemovigilance Programme of

India (HvPI) across the country. This programme has been launched with the objectives of,

monitoring transfusion reactions; create awareness among health care professionals;

generate evidence-based recommendations; advise Central drugs standard control

organization (CDSCO) for safety related regulatory decisions; Communicate findings to all

key stakeholders and to Create national and international linkages (Bisht, Singh, &

Marwaha, 2013). In 2012, a guideline document for reporting Serious Adverse Reactions in

Blood Transfusion Services was also developed by the National Institute of Biologicals (NIB),

Ministry of Health and Family Welfare, Government of India. These guidelines are proposed

for reporting the serious adverse reactions in transfusion medicine by the Adverse Drug

Reaction (ADR) Monitoring Centers under Pharmacovigilance Programme of India (NIB,

2012).

The key characteristics of Haemovigilance Programme in India are, non-punitive,

confidential, independent, expert analysis, credible, system oriented and responsive to the

need. This programme in India has three phases. The Initiation phase (2012-13) that aims to

develop systems & procedures; develop software; enroll participants; start data collection;

conducting zonal workshops for awareness and publication of newsletter. The expansion

and consolidation phase (2013-15) aims to continue enrollment; training of staff; continue

zonal workshops; publication of newsletter etc. The expansion and maintenance phase

(2015-17) is aiming for, maintenance and optimization; Identify gaps & address through

appropriate training; assess feasibility of donor vigilance; rapid alerts and epidemiological

surveillance for TTIs. There are clearly defined roles and responsibilities for each HvPI units.

The Medical Colleges/Institutions/Blood banks are responsible for, collection and causality

assessment of Transfusion Reactions, data entry into “Haemo-Vigil” Software, transmission

of data to HvPI-NCC, NIB. The HvPI- Haemovigilance National Coordinating Centre, National

of 115

Institute of Biologicals is responsible for, review completeness of data Quality, preparation

of SOPs, guidance documents & training manuals, publication of Haemovigilance

Newsletter/ IEC Literature, and communicating recommendations of Haemovigilance

Advisory Committee to IPC. The PvPI, National coordinating Centre, IPC is responsible for

forwarding recommendations of NCC to DCGI- CDSCO. Finally, the DCGI- CDSCO is

responsible for formulate safety related regulatory decisions and communicating Blood &

blood products transfusion safety related decisions to all stakeholders. There are several

IEC measures to increase the awareness of Heamovigilance in India. It is also proposed that

all medical colleges of the country will be enrolled in this program by the year 2016 in order

to have a National Centre of Excellence for Hemovigilance at National Institute of Biologicals

(NIB), which will act as a global knowledge platform.

Hemovigilance programme in India, independent of BTS under DAC, is in its initial phase and

there is a need for concerted efforts to make this effective and successful.

4.2.6. (vi). Technological Innovations in Blood Transfusion Services in India

In the rapidly changing world of biomedical science, automation and continuous technical

advancements are inevitable. However, technical advancements in the field of blood group

serology and transfusion did not have similar rapid advancements as it was perceived that

no machine could take over the highly interpretative role of the skilled serologist (IBMS,

2014). It was proved wrong later, and there have been several technical advancements and

innovations in blood Transfusion Services across the world. Providing health technology has

been a priority in the Millennium Development Goals (UN, 2001). The escalating demand for

safer blood donation and transfusion services; and appropriate use of blood and blood

products is creating the need for more automated blood collection devices, such as

leukocyte reduction filters, blood cell separators, etc. (MedicalBuyer, 2014b) (MedicalBuyer,

2014a). Besides, programmatically, technological innovations are essential to ensure

universal access to adequate, safe and quality blood and blood products.

The technological innovations in India have happened both in clinical and programmatic

management. India has coped up well in managing increasing requirement for

microbiological screening of blood donations in addition to the provision of blood grouping

and antibody screening. Earlier, syphilis testing was mandatory, and now a list of screening

of 115

tests is required for hepatitis B and C, HIV, and malaria, etc. Without the technology, it

would have been impossible to ensure the supply of safer and quality blood and blood

products.

However, the issue is that the benefit of technology are yet to reach across the country, and

the lack of access to diagnostic techniques and blood transfusion technology is not much

discussed (Hazarika & Dutta, 2013). Many states within India have also been facing the

shortage of technological innovations and specialist services that affect the scale up of

Blood Transfusion Services. Besides, in India few hospitals like All India Institute for Medical

Sciences and Technology, New Delhi; PGI, Chandigarh; SGPGI, Lucknow; Nair Hospital,

Mumbai etc., have adopted new technological innovations in Blood Transfusion services

whereas other smaller hospitals are not able to adapt to the situation.

The key programmatic technological adaptations in Blood Transfusion Services is,

i. Electronic Integrated Blood Banking System (e-Blood banking)

Although policies and guidelines are prescribed by governing bodies at national level,

the implementation and efficiency of absorption of these policies & guidelines have

been dependent on state’s capacities. Some of the states have gone beyond the

prescribed levels by establishing a very efficient system. They are, Odisha and

Maharashtra, especially Odisha’s has been recognized as a model by DAC (NACO, 2013).

In 2011, National Rural Health Mission, Orissa, with the support of the State Blood

Transfusion Council and the Odisha State AIDS Control Society started e-blood banking

services that linked 59 government blood banks with the expansion plan of linking all 81

in the state (Mohanty, 2011). E-Blood Bank is an integrated web based blood bank

automation system that interconnects all the Blood Banks into a single network. The

Management Information System (MIS) refers the acquisition, validation, storage and

circulation of information which will also be able to put together the diverse data into

comprehensible reports to support decision making from effective donor screening to

optimal blood distribution to the end user (NRHMOrissa, 2014). This process facilitates

online access to group-wise blood availability in the blood banks so that they can place a

requisition of a particular blood group in a blood bank near to them. People can access

of 115

the information on blood stock availability through online, SMS & IVRS System, as well.

Tracking the orders of blood bags is also made easier, and the user can also check the

status of blood bags issued by the respective blood banks. This system manages the

entire activities from blood collection both from camps & hospitals till the issue of blood

to the user (eIndia, 2012). The Odisha model of integrated e-Blood Banking system has

led to increased efficiency by bringing in accountability, transparency and easy access to

information. Through this initiative, the challenges in BTS have been considerably

alleviated with the use of technology, a particularly web-based system which further

enhances the case for adapting integrated e-Blood banking in other states.

Following the successful implementation of this initiative, e-blood banking system has

been initiated in Kerala as well (NewIndianExpress, 2012). However, the effectiveness of

its functioning is not known.

ii. Nucleic acid testing (NAT) in Karnataka

Nucleic Acid Testing (NAT) method is an advanced screening technology that reduces the

window period of transfusion transmissible infections (TTIs) and helps improve blood

safety (Chandrashekar, 2014). This method screens the genetic material of the disease-

causing organisms which can detect the infection faster than the conventional serology

tests. ID-NAT detects HIV-1 within 4.7 days; HCV within 2.2 days as against relatively

very longer period through the conventional ELISA (Yasmeen, 2013).

In Karnataka, the blood bank at Bowring Hospital, a government run institution adopted

this method of screening in coordination with a private partner, since June 2011. This

bank tests an average of 300 samples every day. A total of 1.3 lakh blood samples of

donors from 30 government blood banks across the State have been tested till 2013

since the inception(Phadnis, 2013; Yasmeen, 2013).

of 115

4.2.6. (vii). Integration with the Health System and Convergence with NRHM, other

departments and Ministries

Access to sufficient and safe blood and blood products provided within a national blood

system is a vital component in achieving universal health coverage. It is the responsibility of

every government to provide effective leadership and governance in developing a national

blood system that is fully integrated into the health-care system, consisting of all the

organizations, institutions, and financial and human resources whose primary purpose is to

meet the transfusion needs of all patients within the country (WHO, 2013c). The national

government is also responsible for the provision of adequate and supply of safe blood and

blood products, and their rational use and should be an integral part of the country's

national health care policy and system which should be supported by a strategic plan and

appropriate legal instruments (WHO, 2011). Besides, an effective national blood system

requires close coordination and collaboration with relevant government ministries, national

reference laboratory and agencies and institutions for public health, surveillance, regulation,

accreditation and plasma fractionation (WHO, 2011). It is also essential to establish a

mechanism for the coordination of all public, private and voluntary sector institutions,

organizations and agencies involved in the national blood system (WHO, 2012c)

In India, the major causes of maternal deaths in India are due to antepartum hemorrhage,

post-partum hemorrhage. According to a the Sample Registration Survey, postpartum

hemorrhage accounted for nearly 38% of all maternal deaths(Registrar General, 2006).

Hemorrhage during pregnancy is generally not predictable and blood transfusion can be

helpful in management of such hemorrhage. Thus, establishing blood transfusion services

at all such institutions conducting deliveries is vital. Especially, in India, the District hospitals,

CHCs and FRUs are required to have direct linkage with the blood bank or blood storage

facility as FRUs treat emergency cases (GOI, 2011). This requires convergence of the

program with NRHM, other State health departments, ESI, CGHS hospitals, etc. Convergence

is also necessary as some commentators believe due to continued governmental negligence,

blood-transfusion services in India are a highly-fragmented mix of competing independent

and hospital-based blood-banks, serving the needs of urban populations (Ramani et al.,

2009). There is also a need for strong coordination between health care facilities and blood

banks or blood storage units, as lacunae in this will be a serious hurdle towards full

utilization.

of 115

The main aim of convergence with NRHM is to ensure availability of whole human blood or

its components to FRUs/CHCs/PHCs. The Drug and Cosmetics Acti, was amended with the

objective of setting up blood storage/ transfusion services at these health facilities

functioning under NRHM without taking a license for blood storage/ transfusion facilities.

However, this exemption is applicable to those centres and identified FRUs that are

transfusing blood and/or its components less than 2000 units per annum. In order to

ensure the safety and quality of blood and/or its components to be stored in such blood

storage centers, the Ministry of Health and Family Welfare notificationii laid down some

conditions that have to be met before getting exemption from the purview of taking of a

license from the respective State Drugs Controllers. The Staff needed for a Blood Storage

Centre - one existing Medical Officer and a lab technician, trained on for three days on

‘Storage and utilization of blood’ from some recognized centre. Guidelines for Setting up

Blood Storage centers, by Department of AIDS Control were introduced (NACO, 2007b). DAC

also supplied blood bank refrigerators of different types to a number of States.

Department of Family Welfare, Government of India, took up the provision of equipment

and training of staff for blood storage and transfusion in health facilities at identified FRUs,

where emergency obstetric care services/institutional deliveries are being conducted. DAC

has linked these centers with the nearest Regional Blood Transfusion Centre (RBTC) for the

supply of screened blood on a regular basis and is regularly training the staff attached to the

storage centers. Also, voluntary blood donation programme has been proposed to be

clubbed with Anaemia Programme (NACO, 2013).

The outcome of this convergence initiative is that, in 2013-14, there are 745 blood storage

centers functioning across the country. A minimum of 10- 15 units are available at the

centers according to their consumption(NACO, 2013). According to Planning Commission’s

NRHM evaluation report 2011, there is a need to strengthen blood storage facilities in FRUs

and sub-DH health facilities. In a few states like Assam and Jammu and Kashmir, shortage of

blood banks and ill- functioning blood storage units is a serious snag towards full utilization

of health facilities like FRUs especially for emergency and surgical services. Blood

components are still not available for patient use as per licensing regulations at these blood

storage centres (GOI, 2007).

of 115

In addition, according to National Facility Report RCH II, only 67.5% of the District Hospitals,

27.2% of the FRUs and 15.8% of the CHC were having linkages with the blood banks and

regular blood supply was available only in 60.5% of the District Hospital, 27.% of the FRUs

and 10.5% of the CHCs which is far from satisfactory (IIPS, 2005). Kerala, Tripura and West

Bengal are the only three states with all the hospitals having linkage with district blood

banks. The Health and Family Welfare statistics 2013 reported that only 14% of the CHCs

have BSCs in which only 11.8% of CHCs in high focus NRHM states have BSCs. This recent

data indicates an increase in the Blood Bank/ Blood storage units in the district hospitals

that are 74%. It also indicates that only 42% of the functioning FRUs have facilities for blood

transfusion (GOI, 2013). According to the District Level Household and Facility Survey 2007-

08, only 9.1% of the CHCs have blood storage facilities which are designated as First Referral

Units (FRUs); fully operational blood bank is available in 69 percent of the district hospitals.

(IIPS, 2010).

4.2.6. (viii). Efficient Supply Chain Management and Quality Assurance

The blood transfusion service should have an efficient supply chain management in place to

monitor and manage stocks in order to maintain an uninterrupted supply. Continuity in the

supply of the assays reagents and consumables required for testing depends on reliable

procurement and supply systems (WHO, 2010b). A national procurement system will

require the development of specifications for equipment, test kits, reagents and

consumables and assessment of the quantity and types required. The implementation of

centralized bulk procurement with an efficient distribution system is likely to provide

significant cost savings, simplify stock management and enable an uninterrupted supply of

assays and reagents to be maintained.

In India, DAC supports the procurement of equipment, test kits and reagents as well as the

running expenditure for government blood banks, and those supported by DAC (NACO,

2013). Most of the key items required for the programme - equipment, blood bags,

reagents, including test kits (HIV-Rapid), HIV-Elisa), HBs Ag-Rapid), HBs Ag-Elisa), HCV-Rapid,

HCV-Elisa and other items such as ARV drugs, STI drug kits, etc. are centrally procured by

Department of AIDS Control and supplied to peripheral units and State AIDS Control

Societies (SACS)(NACO, 2013). A consortium of 5 laboratories is responsible for quality

of 115

assurance of reagent kits-HIV, HBsAg, and HCV. In order to ensure quick maintenance, most

of the equipment procured by DAC are under comprehensive maintenance or warranty.

Procurement of goods is done through bids and minutes of pre-bid meeting and bid opening

minutes are uploaded on the websites in order to ensure transparency. After central

procurement, the goods are all distributed to the facilities directly. A comprehensive

“Procurement Manual for National AIDS Control Programme (NACP III)” has been

developed, and the respective officers’ have been continuously trained on Procurement

(NACO, 2007f) .

Supply Chain Management of blood and blood products is vital in blood transfusion services.

Usually, the problems in India arise in terms of storage capability over time and the ability to

move units from low demand to high demand centres to avoid outdating (Tirupathi, 2013).

Central blood banks need to visualize the trends to meaningfully identify demand and set up

a dependable supply chain system for effective utilization. In order to ensure quality,

guidelines for supply chain management of blood and blood products is essential in terms of

maintenance and use of blood cold chain equipment and management.

Few initiatives in India which strengthened the supply chain process of BTS services India,

one among them is Blood Transportation Vans which are used for,

• Transportation of collected blood from Voluntary Blood Donations (VBD ) camps to

mother blood bank for processing; after processing, blood is being transported in

these vans from mother blood bank to storage centres in FRUs in order to ensure

blood availability in the remote areas (NACO, 2011a, 2013)

• Transportation of blood from the linked RBTC to the Blood Storage Centre. Each

RBTC is linked to 6-8 BSCs in order to supply blood units under proper conditions and

storage. DAC provided 250 refrigerated Blood Transportation vans to the

RBTCs/district Blood Banks during NACP-III. These vans transfer blood units to the

BSC on a regular basis and also on demand/ emergency situations.

• Blood collection and storage vans - With a capacity to stock 300 bags of blood and

space to accommodate four blood donors simultaneously, donating blood has

become little easier in the rural areas. The blood is then transported for processing

in the same vans (NACO, 2013).

of 115

According to DAC, efforts are being made to streamline the Supply Chain Management of

various supplies to consuming units includes providing training on Supply chain

Management to the Procurement Officials of SACS in addition to hand-holding support to

State AIDS Control Societies is being provided by the procurement division at Department of

AIDS Control (UNAIDS, 2012).

4.2.6. (ix). Legal, Regulatory and Policy Dimension of Blood Transfusion Services in

India

Laws and Regulations

Laws and regulations related to BTS in India are a part of the Drugs and Cosmetics Law, 1940

under section 3(b), as Human Blood and blood components are categorised as a "drug"

because of their internal administration (NACO, 2003). This Act and the Rules provide the

legal framework for regulating the functioning of blood banks, which in turn determine the

blood transfusion service delivery in the country (NACO, 2007a). Since initial formulation,

the act has been expanded, and the rules have been frequently amended to integrate the

concerns; and the amended act came into force with effect from April 5. 1999. Under this

act and its rules, all blood banks in the country need to obtain a license from the Central

License Approving Authority of the Ministry of Health and Family Welfare on the basis of

recommendation of Director, Drug Control of the state by abiding the condition laid down in

the Act and the Rules, that need to be renewed on expiry. The regulatory control is

exercised under the dual authority of the State and the Central government.

A key aspect of the legal provision is that voluntary blood donation in outdoor camps can

only be collected by a licensed Government Blood Bank, Indian Red Cross Society, or a

licensed non-governmental organization designated by State Blood Transfusion Council

constituted by the State Government. The legal framework concerning blood safety issue

has been adequately outlined in the Schedule XII B of the Drugs and Cosmetics Act/Rules,

which demands mandatory testing of blood for blood transmissible diseases, including

HIV(SolutionExchange, 2006). The rules have been further amended providing adequate

testing procedures, quality control, standard qualifications, and experience for blood bank

personnel, maintenance of complete and accurate records, etc. In 2001, a notification was

of 115

issued to regulate and streamline the blood storage centres, which will help community

health centres, small hospitals / nursing homes whose requirement is less than 2000 units of

blood per annum.

As Blood transfusion can be lifesaving and also can be fatal, it comes under fundamental

rights of a citizen according to Article 21 part III titled fundamental rights of the Constitution

of India. Besides, the Indian Penal Code(IPC) Section 269 has provisions for fine and

imprisonment for a negligent act likely to spread infectious disease dangerous to life and

section 270 of the Malignant Act likely to spread infection of disease dangerous to life

covers blood transfusion and blood banking in all aspects(GOM, 2014).

The consumer protection act also gives protection, whereby patients who received deficient

services from medical professions and hospitals are entitled to claim damages under the

Act. Blood banking service comes under this Act, and both donor and recipient may take the

cover of this Act.

Few judgements and directives correspondingly gave direction to blood safety services in

India. For example, the Supreme Court of India banned paid donations in 1997 and has

ordered the establishment of an autonomous National Blood Transfusion Council and State

Transfusion Councils (Pal et al., 2011). The Supreme Court in 1996 had directed the

government to consider the advisability of enacting legislation to regulate the collection,

processing, storage, distribution of blood, and the operation of blood banks. The supreme

court also directed to amend the, Section 80G of the Income Tax Act, 1961 so as to make all

donations to the National Blood Transfusion Council (NBTC) and to the State Blood

Transfusion Councils (SBTCs) eligible for tax deductions from the taxable income of an

Assesse.

In 2012, following a public interest litigation to make PCR test as mandatory, the Gujarat

high court had directed the Ministry of Health and Family Welfare, Government of India, to

constitute a body of experts to examine the feasibility of making PCR tests mandatory at all

licensed blood banks across the country. Subsequently based on the committee’s report,

though the court has recognized the superiority of PCR Test compared to ELISA, it refused to

of 115

give an order to make Polymerase Chain Reaction (PCR) test or the nucleic acid amplification

test (NAAT) compulsory instead of ELISA to screen HIV infection during blood transfusion.

In 2013, the Gujarat high court once again gave a landmark judgment, which clearly stated

that it would be the duty of the state government to appoint sufficient number of inspectors

to ensure that rules for running of blood banks are strictly complied with as per the National

Blood Policy. It ordered that all blood banks should display a rate card of the blood as per

NBTC rates. It also directed the committee to ensure that the blood banks in states do not

indulge in profiteering or charge more than the rate prescribed by the ministry of health and

family welfare and to Evolve a policy to make it clear as to what constitutes profiteering

including the penal consequences of the offence of profiteering.

Following these landmark judgments, the Department of AIDS Control, Ministry of Health

and Family Welfare, and the National Blood Transfusion Council, in its 24th

Governing Body

council approved a guidelines for recovery of processing charges for blood and blood

components. The guidelines also indicated that it is mandatory to provide blood free of cost

of those who needs blood transfusion regularly such as, Thalassemia, Haemophila, sickle cell

anaemia, and another blood dyscrasia requiring repeated blood transfusion. All these legal

measures and key decisions by the Government, helped to ensure transparent procedures

in blood transfusion services and increase the access to safe and quality of blood.

Blood Transfusion Policies in India

Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and quality systems

are the major challenges to the organization and management of blood transfusion services

in order to achieve maximum safety for any nation (NACO, 2007h). Keeping these

challenges in mind and to ensure quality, equity in blood transfusion services, National

Blood policy was introduced in 2002 which will also ensure the implementation of the

directives of Supreme Court of India - 1996.

This policy aims at ensuring easy accessibility and adequate supply of safe and quality blood

and blood components collected from Voluntary and non-remunerated blood donors in

of 115

well-equipped premises, which is free from TTIs, and is stored and transported under

optimum conditions. Transfusion under supervision of trained personnel for all who need it

irrespective of their economic or social status through comprehensive, efficient and a total

quality management approach will be ensured under the policy (NACO, 2007d). The

national blood policy also defined the authority and responsibility for service, the

importance of voluntary blood donation, the means of funding, and legislation required to

ensure safe and quality blood transfusion services in India. Establishment of blood

transfusion councils and focusing on an integrated strategy for blood safety were

emphasized the National Blood Policy which is of great value.

The policy in 2002 followed by Action Plan for Blood Safety in order to operationalize the

priorities and objectives set out in the national blood policy and to address the infirmities in

existing systems in terms of quality, structures, linkages and procedures that govern the

blood transfusion services in the country. Each Section of the Action Plan reiterated an

objective mentioned in the National Blood Policy (NBP), 2002, and all objectives of the NBP

were addressed. Each objective cited is followed by a listing of diverse and wide ranging

operational strategies whose implementation calls for a multi-agency response from the

government, the private sector, the Red Cross Society of India, the Indian Council of Medical

Research, Medical Council of India, NGOs / CBOs and others.

4.2.6. (x). Ethical Issues in BTS Services

In parallel with the increasing awareness of ethical issues in every field of health care

and research in India, knowledge and awareness are mounting in transfusion medicine, as

well. However, the adherence to the international code of ethics is very low in India

(Elhence, 2006). In 1980, the International Society of Blood Transfusion (ISBT) endorsed its

first formal code of ethics that was later endorsed and adopted by the World Health

Organization and the League of Red Crescent Societies. A revised code of ethics for blood

donation and transfusion was endorsed in 2000, with inputs from various concerned

organizations that gave recommendations regarding the ethical responsibilities of the

donor, the collection agency and the prescribing authority toward the well-being of the

recipient and the community at large.

of 115

The 1996 Supreme Court’s order of banning professional and commercial blood sellers has

made a significant impact practicing ethical principles that has also directed the government

to formulate a national blood policy. The National Blood Transfusion Council, with the

National Blood Policy as a tool, and the Drugs Controller, with the help of the Drugs and

Cosmetics Act, now aim to ensure blood safety and ethical transfusion practices in India.

According to the present guidelines, consent for testing is taken, and the donor is given the

option of receiving the results. However, following the standard guidelines is not present

universally which leads to ethical issues. The Code of Medical Ethics that is binding on

doctors honours confidentiality. However, in a court of law in India, this privilege is not

absolute but qualified. Doctors can reveal information in the interest of individual or general

welfare of society and when there is no mal-intention.

Ethical issues are mostly violated in relation to the patient in India. Patients all over the

country do not have access to safe blood free of charge, the option of giving consent and

choosing safer alternatives. In addition, ensuring voluntary non remunerated donation,

anonymity between donor and recipient, wastages, donor confidentiality, donor notification

and donor consent are the areas still need improvement. It is also important address all the

other issues in the international code of ethics for blood donation and transfusion to make

India achieve international standards.

of 115

SECTION SECTION SECTION SECTION –––– BBBB

Site Specific ObservationsSite Specific ObservationsSite Specific ObservationsSite Specific Observations

of 115

5. Site Specific Observations

The objective of the site specific observations was to understand the current status of the

blood banks in terms of human resources, equipment, supplies (reagents, kits, etc.),

performance, VBD camps, and quality management practices; the gaps, issues and

challenges of blood transfusion services in their respective areas.

As mentioned in the methodology earlier, 15 blood banks from five zones were visited for

observations. First Referral Units were also visited for observation wherever possible. In

addition, a Joint Director of Blood safety and a state drug controller from each zone were

interviewed in-depth to get their views on the management of blood transfusion services in

the region.

A team of assessors comprising of two experts in Transfusion Medicine for each zone

(South, North, East, West and North East), and observers from DAC, CDC and CMAI, visited

the predetermined sites. The experts were selected from the panel, available with DAC who

had experience of conducting such assessments in blood banks.

The key observations have been analysed thematically and presented in sequence. The

differences between zones have also been captured. The key themes include, Human

resource,

5. I). Human Resources

Staffing pattern: The staffing in blood banks is supported from either budget allocations

from the state health services or State AIDS Control Societies. However, staff vacancy exists

at different levels primarily due to lack of allocation of funds. In addition, the positions are

not filled or lying vacant in many places, in spite of sanctioned positions. This situation is

observed relatively higher in Government facilities compared to Voluntary / Charitable

institutions. In few states, the staffing positions funded by the respective SBTCs have been

withdrawn due to low workload at the facilities that is mostly due to a reduction in the

number of voluntary donors. The range of staff vacancies indicate more variation on the

North (0 to 75%) and South (0 to 50%) compared to the other zones where the situation is

of 115

“Whenever there is a shortage of staff, they

extend our duty hours. But we do not get any

benefits”.

– Lab technician, IBTM

“I am a pathologist from the hospital side

and on additional duty as Blood bank

Medical Officer. One Sr. Lab Technician

from UP Govt. is posted who is also retiring

in October 2014. There is one more

technical staff through UPSACS. With this

manpower how do you expect us to ensure

quality?”

– A BB MO in charge

“We need to give power and authority to

Blood Bank Medical Officer to make

decision and handle local administration”

-JD BS of SACS

better and 85-100% positions are filled.

Moreover, vacancies are observed

higher in the District level blood banks

(0 to 75%) compared to higher

facilities.

In few facilities, medical officers

exclusively for blood banks are not

available and in many places, only

technicians are posted. In few sites, it was also suggested have staff such as PRO, social

worker, counsellor, quality manager, data entry operator and driver which would increase

the effective functioning of the blood bank activities.

It was reported that there is a disparity

between state government funded

technicians and SACS funded technicians

in terms of salary, capacity building and

work load. The workload and

responsibility of the SACS appointed/trained technicians were reported to be higher as they

are required to carry out the data management work in addition to their technical

responsibilities.

Morale of the staff: The morale of the staff appointed by SBTC/SACS was found to be lower

as they perceive that they are given consolidated salary, and benefits are reported to be not

on par with the other state government employees. The increased workload combined with

a lack of incentives was indicated as

one of the reasons for the high staff

attrition in these facilities. The

interviews with Joint Directors (BS)

highlighted the difficulty of maintaining

or retaining the trained personnel due to frequent transfers in addition to staff attrition due

to perceived factors like, contractual position with consolidated pay; salaries and

of 115

There is no structured program to follow

up the training participants and observe

the impact of these training programs and

quantify actual change of practice.

- Joint Director(BS) of a state

“The knowledge levels of Lab technicians are

at diverse levels and most of them do not

understand English. In addition, lack of hands

on training results in poor outcomes of

capacity building initiatives. CPR training is

also essential for all Blood bank Staff”

–DD BS of a SACS.

increments not on par with the government staff; and increased work load compared to the

state government employees.

Coordination within the facilities: In few facilities, lack of active participation and

involvement of the pathology department was reported.

Capacity Building: It was observed that the majority of blood bank staff have not been

trained in advanced technology in Blood Transfusion Services. Many of them still follow

outmoded technology for pre donation checking, Blood Grouping and compatibility testing.

Though there has been improvement

in the training status of staff, not all

technical staff have been trained in

Blood Safety under SACS. A few sites

that have given information on

training indicate that more than 75%

of staff have been trained.

The Joint Directors (JD) of Blood safety in the states expressed that regular capacity building

programs and exposure visits have been carried out to strengthen the capacity of blood

bank personnel. There are 17 DAC identified training centres, however, they are not

geographically well distributed. The

training centers in the state conduct an

average of 3 to 4 training programs

annually using the DAC approved training

curriculum with the financial support from

DAC. It was also perceived that capacity building component witnessed several challenges

due to shortage of manpower (trainer and trainees) and, regional level coordination.

Training facilities are facing challenges due to factors such as, uneven knowledge level of

Lab Technicians; ability to understand language (English); short duration of Training;

insufficient fund for logistics and accommodation; lack of hands on Training; and lack of

updated training modules. Lack of training for Medical Officers and Nurses in rural areas

has also been stated as one of the challenges. The importance of having of more training-

of 115

“Supplies are becoming increasingly erratic – especially

over the last year. Most times, we are left with no choice

about kits and blood bags to be purchased except to go

for whatever is available at short notice that compromise

the quality”

– A Blood Bank Medical Officer.

of-trainer/trainers, and training centres; and training for private blood banks were

emphasized as key requirements.

Besides, JDs of SACS mentioned that they are carrying out mentoring visits to the facilities.

For instance, a minimum of one visit is being carried out by TANSACS in a year, whereas it

was 2 visits with MACS. It was pointed out “training needs, pre & post counseling,

cleanliness, logistics, bio-safety, equipment management and voluntary blood donation”

were the key areas of focus during the supportive monitoring visits. Technical experts from

medical colleges or other BCSU’s, retired blood bank personnel’s or core committee

members were involved in the monitoring visits. Lack of staff and frequent changes in SACS

staff were quoted as the challenges of having regular mentoring and monitoring visits.

5. II). Equipment and Supplies

5. II. a) Supplies

It was reported that supplies from DAC have become increasingly irregular especially over

the last year that led to the shortage of supplies (2013). In these situations, the

Government Blood Banks were asked to purchase supplies from local fund that is through

state government budget.

Besides, the blood banks were

left with no choice in terms of

the quality of kits and blood

bags and forced to buy

whatever was available.

However, it was observed that the voluntary / charitable institutions were able to overcome

these situations as they were able to use their own funds to avoid stock outs. Facilities in

South, North & East zone, have reported having inadequate supplies compared to their

western and northeastern counterparts. Most of the higher level facilities (major and model

blood banks) reported having adequate supplies. There were vast differences in the supplies

across zones, as mentioned above, clearly indicating the lack of initiatives by the respective

SACS.

of 115

“There are 9 sanctioned lab technicians. Only

two are qualified. Other seven are only 10th

passed with CMLT qualification and on

contractual pay of Rs 3,000 per month”

- A BB Medical Officer

“Most of the crucial equipment are not working

as there is no AMC by SACS. So, how do we

manage the equipment?”

– Staff, Central Blood bank

The Joint Directors of SACS also highlighted continuous issues of erratic supply and mostly

short supply; and supply chain management issues. The blood banks in Tamil Nadu state

have been addressing the issue of shortage of supplies through state government funds. .

5. II. b). Equipment and Maintenance

In few facilities, critical equipment like refrigerator, ELISA reader & washer, Serological

water bath and autoclave were not adequate in number or not available. Some of the blood

banks have been facing issues in transporting kits and storing. In few facilities, the bags are

stored in non-a/c rooms. The Joint Directors reported that they find it difficult to cover the

entire requirement of blood bank due to limited funding availability.

It was observed that there is a shortage of trained manpower to maintain the equipment

internally. Most of the temperature

monitoring are manual on charts that

require constant human attention.

Though there are annual

maintenance contracts (AMC) for some

equipment, there is absence monitoring mechanism to ensure quality or quantum of work

to maintain the equipment. During emergency situations, Blood banks do not have an

option but to go to other private operators to get machines repaired at additional cost.

Facilities in South & West zone have reported having regular annual maintenance contract

for most of the equipment. Other zones

lack this system, leading to inefficient

functioning and lack of quality service

provision. Most of the higher facilities

(major and model blood banks) do not

have adequate maintenance facilities

compared to district level facilities which have good systems. This could be due to higher

cost of AMC.

Calibration of equipment is not being performed at desired frequency in many government

centres as calibration is reported to be expensive. Details of equipment were also not

of 115

“We only get 5 units per month from our

mother blood bank that is not enough. Our

requirement is 10 per month. The mother banks

find it difficult to fulfill their own requirement.

We are forced to refer patients to other higher

facilities in case of stock out”

– MO in charge of a storage centre, CHC

maintained, for instance, equipment were not having ID number and usages. It was also

observed that most equipment in few sites are kept idle and not utilised at all. It is also

evident that there is no structured condemnation and replacement plan for non-functioning

equipment both under Government budget and DAC provision.

5. II. c). Adequacy of Blood and blood components generated

Majority of the blood banks (Model, BCSU & Major BB) are meeting the demand for blood

thanks to the increasing number of blood donation camps. Facilities from almost all the

zones are reporting adequate number of camps for collection of blood. Higher facilities like

major, BCSU and Model blood banks collect at a range of 3,000 to 35,000 units per year.

District level blood banks collect an average of 1000 to 9000 units per year with the

exception of a Voluntary BB in Bangalore that collects 35,000 units/year. Though blood

storage facilities do not conduct camps, few sites which were visited during this assessment

(CHC, Jowai, Meghalaya) do have a huge potential for conducting camps and upgrading

themselves to District Level Blood Bank (DLBB).

However, the blood banks lack a structured program to organize camps as well as to recruit

donors. They are heavily dependent on Non-Governmental Organizations (NGO) or religious

organizations to organize camps. During the time shortages especially in summer and fever

seasons, medical officers are forced

to request these organisations to

conduct camps or to bring in

donors. Though it creates a good

link with the community based

organizations, the over dependence

of them sometimes lead to a

shortage of blood availability.

Facilities facing challenges in organising camps are depending on mobile donor units.

However, due to shortage of staff, they use the services of trained DMLT students

(technicians), nursing students, post graduates or medical students (doctors) and contract

employees (support staff) which usually lead to increased rejection in the bags with reasons

of “incomplete collections” and “vein/needle blocks”.

of 115

Effective linkages within Blood Banks and

geographical mapping were the

requirements to be fulfilled in order to

improve the access to blood and

component.

- JD of a SACS

“100% of our collection is from voluntary donors, and

30-40% is from repeat voluntary donors mostly from

a rich source of young, healthy, educated and socially

aware voluntary donors. We conduct camps 5 days a

week and sometimes twice a day. We maintain a

department for donor recruitment whose role is to

develop and sustain the contacts required, and to

organize a calendar for this intensive schedule. We

have also effectively leveraged the influence of

socially committed leaders in the community to

organize and mobilize voluntary blood donors”

– A charitable Rotary blood bank,

Component Separation: Separation of whole blood was found to be very low in certain

facilities and the primary reason is lack

of demand for components from the

clinicians. This stresses the need for

regular training of clinical staff on the

rational use of components. According

to interviews with JDs, a range of 45

percent to 80 percent of whole blood is separated as components; it was also mentioned

that adequate facilities are available for component separation and storage in the states.

However, in Meghalaya only 2 BCSU’s are functioning for the entire state, but located in one

district. The JDs expressed that though there are no structured program or guidelines to

improve access to blood and components “Networking with Government run blood banks to

transport blood with existing transport facility, inception of ‘blood on call’ system and

process of increasing Blood Banks, BCSU's and BSC's” were the methods adopted so far to

improve access of blood and blood components.

5. II. d). Voluntary Blood Donation

Overall, the rate of voluntary

blood donation has been

increasing across facilities during

the last five years. Most facilities

reported a higher proportion of

voluntary donation especially

from camps. The volume of blood

units collected under voluntary

blood donation was found to be

low between the month of May

and July. VBD was reported to be

poor in North East zone (10- 50%) followed by North zone (60 - 80%) whereas other zones

reported high VBD rates (>95%).

of 115

All the facilities do not maintain the data related to repeat voluntary blood donation,

however, it was observed that the rates of repeat donation vary from 2 to 40%. This was

between 10- 40% in south zone facilities and 2- 7% in North zone facilities. Facilities in the

other zones were not able to provide data related repeat voluntary donors. The lower rate

of repeat donation could be due to the increasing number of camps organised across the

cities, which leads to lack of importance on motivating repeat donors.

Few blood banks do maintain a directory of voluntary blood donors and agencies who can

organize camps, which is found to be useful to approach them in times of emergency. Donor

motivation and felicitation programs have been organized by SBTC in some blood banks.

Few blood banks stated that they need sufficient funds to conduct outdoor blood donation

camps. It was also suggested that the Department of Education should issue directions to

educational institutions (colleges) to conduct blood camps in order to increase the voluntary

blood donation. In few sites, blood banks have PROs who manage and organize camps, but

PROs do not exist in most district level blood banks, in the Government side. It was reported

that having PROs in all the blood banks will increase the proportion of voluntary blood

donation.

5. II. e). Blood screening mechanism & discard rates

It was observed that screening of blood was in conformity with standard guidelines.

Screening for TTIs such as, HIV, HBV and HCV have been done by ELISA; Syphilis by RPR test;

and Malaria by microscopy. Positive samples are retested by rapid test. Donor notification

and referral to ICTC are happening in most facilities. However, there is no feedback or

follow-up mechanism for these donors who are referred. There is not much of a variation

across the types of blood banks in terms of screening for TTIs. Though all the facilities are

screening for TTIs, the facilities in East zone seldom do haemoglobin estimation that is

critical and require strict compliance to standard procedures.

In few zones, screening is being done before collection and the donors are deferred if they

are found positive for any TTIs. This process is not confidential and unlinked. Discard rates

are low in many facilities due to selective collection and appropriate use of blood. The

of 115

discard rates are consistently low due to pre-screening deferral, as well. It was observed in

few facilities that seropositive blood was discarded without autoclaving. Though, it is not a

mandatory requirement, donors who are tested positive for Hepatitis B and C are not being

given adequate attention and guidance through counselling in most facilities that is an area

of concern.

5. II. f). Standard Operating Procedures and Quality Assurance

Most blood banks across zones have written standard operating procedures (SOPs). Though

North Zone has written SOPs SOP, they are not in compliance to that.

Many blood banks are not carrying out any quality assurance program for Blood screening

for an infectious agent, compatibility testing, component separation, kit and reagent quality.

Only, West zone facilities were observed to have a good national EQA program in place.

Participation in EQA program was found to be better in District level blood banks compared

to all other higher facilities. From the interviews with JDs, it was observed that they hardly

get feedback on EQAS and “there is no consistent participation”. In few facilities, it was

observed that equipment were not being maintained properly and calibrated. Blood banks

found it difficult to check the quality of reagent and antisera prior to purchasing as these are

either supplied by DAC or purchased on an urgent basis when there is short supply.

Most blood banks perform internal quality control (IQC) on cells and serum using pooled

donor cells and serum. Cells used are created in-house from donor blood. Facilities in South

and North East zone reported having effective internal quality Control mechanism and the

other did not report so. Internal Quality control was found to be better in District level

blood banks compared to all other higher facilities. Biomedical waste management

regulation is adhered in most sites; however, few facilities in North and East zone do not

adhere to these practices.

In few sites, staffs of blood banks have not been vaccinated for Hepatitis B which raises

concern on the occupational safety of them. Most blood bank staff expressed their

willingness and desire to participate in EQAS programme, but they face financial restrictions.

This clearly indicates the need for strengthening the IQC, EQAS and adherence to SOPs, in all

blood banks especially in the North and East Zones.

of 115

“We have linkages for the supply of blood and

components to blood storage centres in 14

Hospitals and district blood banks in remote

northern Karnataka. We feel that captive nature of

Blood storage centres to selected facilities must be

removed and there should be free access to transfer

blood across facilities in the vicinity”

– A charitable BB, Bangalore.

“We have a plan to link 11 storage centers of which

2 are already functional. We also have ‘Blood On call

‘scheme started. We are yet to evaluate the outcome

of it”

–MO of a BB

5. II. g). Referral and linkages

It was observed that there is a significant improvement in referral and linkages in blood

banks. Facilities in South zones were reported to have good and effective linkages with an

average of 5- 15 hospitals in the vicinity; the blood storage centres in the Northeast have

good linkages with higher facilities;

however, facilities in North and

West zones have poor referral and

linkages with PHC/ FRUs. East zone

did not report the status. Most

District level blood banks & Major

Blood banks have better linkages

with tertiary care centres. Higher

level Government facilities and IRCS have good linkages with blood storage centres in

hospitals, and district blood banks in the vicinity. Besides, few blood storage centres were

observed to have effective linkages

with their mother Blood banks, for

instance CHC Jowai with mother

blood banks in Shillong. However,

supply of blood to BSC has always

been low due to shortages in the

mother blood bank itself. However, it was also observed that some blood banks are not

effectively linked to any PHC/BSU/FRU, Model Blood Banks, Tertiary Hospital and NGO trust.

It was suggested by staff that blood banks should be effectively linked to other blood banks

and BSUs in that area for effective utilization of excess blood and to permit transportation

of blood across state borders in ensuring access to blood and components in border areas.

of 115

“Maintenance of mobile vans is not fully

supported. Cold chain maintenance is also a

problem”

–DD BS of a SACS

“Clear guidelines and rules regarding exchange of

blood between blood banks are required”

–DD BS of a SACS

5. II. h). Transportation of blood and blood products

It was observed that there is a

significant increase in access to blood

and blood products across the country

due to continuous and various efforts.

According to the JDs in the states, the

states have vehicles (range: 0-18 per state) to transport the blood during the need and to

ensure efficient supply chain management. In-addition to the vehicles, blood transportation

boxes, are available in states like Meghalaya. The availability of mobile blood bank (except

MACS) has also improved the situation. For instance, Tamil Nadu has three mobile blood

banks of which two were supported by

DAC and the remaining was the state

government funded; Maharashtra has

two; one with GMC Nagpur and one

being shared by all centers. The JDs also

expressed the challenges of operating mobile blood banks with inadequate staff; underpaid

drivers; poor scheduling of payment to drivers; low budget allocation for equipment

maintenance; and difficulty in maintaining the cold chain. The need for customized blood

mobile units that suits to terrain of few states was stressed by the JDs.

5. II. i). mmunohematology parameters

It was observed that there are huge variations in Immunohematology testing across

facilities. In District level blood banks, primitive techniques such as, slides and tile method

are used for blood grouping. Cross matching is being done by tube method and occasionally

by direct and indirect coombs’s test. In higher facilities, blood grouping is done by tube

method in addition to reverse grouping. Coombs test is also performed if required.

Grouping & cross matching: Facilities in North and East use tile and slide method for blood

grouping respectively and the remaining use tube method. Facilities in East use slide

method for cross matching and all other facilities use tube method.

of 115

“Technical input requirements and the data

generated is very high in all states. We are in

need of technically qualified persons-

preferably MD transfusion medicine to

initiate and sustain research on such areas”

- A JD-BS

5. II. j). Record maintenance, Documentation, Reporting& Monitoring

In most facilities, though registers are in place as per regulatory requirements,

completeness is a concern. Especially, facilities in East zone do not maintain appropriate

registers and most are incomplete. Record maintenance and documentation are at below

average level in BCSUs and major blood banks, and other facilities are adhering to the

requirements.

In few sites, donor registration form needs revision. Referral register of sero-reactive

donors to ICTC and the outcome is being maintained in many sites. Cell and serum grouping

register is also not maintained in few places. Few facilities do not have computers and

internet facility.

The JDs mentioned that they are using SIMS

for data collection, whereas, MSACS and

MACS still use CMIS. According to them,

monthly reports are regularly sent to DAC,

but they hardly get feedback. It was also

stated that the data are helpful for program

planning of SACS. Especially, the analysis facilitates the blood banks to effectively plan to

improve their blood collection and component preparation during outbreak of certain

diseases. It was also reported that the NERO provides technical support in program

planning by facilitating analysis of monthly and quarterly CMIS outputs.

5. II. k). Regulation and Licensing

According to the drug controller in Tamil Nadu, only 40% of the blood banks’ licenses were

renewed in the last year, and the reasons were mainly due to the delay in rectification of

defects by the blood banks, noticed during the joint inspection. It was also reported that

nearly 0.5% of blood banks license is cancelled every year due to non-compliance of the

rules and regulations. However, in Meghalaya 100% of blood banks’ license were renewed

in the last year.

of 115

The Drug controllers accompany the JD blood safety during joint supervisory visits. The visits

are conducted only once a year. The coordination between SACS and SBTC for these joint

visits is the key challenge expressed by the Drug controllers.

of 115

SECTION SECTION SECTION SECTION –––– CCCC

Issues, Challenges and RecommendationsIssues, Challenges and RecommendationsIssues, Challenges and RecommendationsIssues, Challenges and Recommendations

of 115

6. Issues, Challenges and Recommendations

6.1 The Structure and systems of Blood Transfusion Services in India

Though there is a significant improvement in the blood safety services, there are several

structural and systemic issues that need to be addressed.

• In India, Blood Transfusion Services are highly fragmented and different

organizations play different roles in licensing, controlling, and regulating blood-banks

(Ramani et al., 2009). Two parallel systems are in place to monitor the blood-safety

Programme in India—NBTC/SBTC and NACO/SACS. While the Department of AIDS

Control (DAC) was responsible for ensuring the safety of blood supply, it had limited

ability to enforce a ban on professional donation or even to strengthen licensing

requirements. National Blood Transfusion Council is the apex policy-making body for

blood transfusion services but these bodies have an advisory role and have no

control over the blood banks (Pal et al., 2011). Problems and issues facing the

provider and the end user in each of these settings are, therefore, unique and each

one needs to be addressed in the context of our current organizational structure.

Merits and demerits of working towards a centralized system need to be carefully

evaluated. Implementation of any change requires a careful feasibility study and the

strategy of moving towards such a system planned in exquisite detail before

considering implementation.

• The absence of a centralized national transfusion service leads to lack of

accountability on many fronts – from donor recruitment to component preparation,

testing protocols, appropriate use of blood / components and costing. A major

problem plaguing blood banks is poor monitoring and control because of the

multiplicity of agencies involved (Tripathi, 2005).

• All SBTCs are functioning under the SACS except Maharashtra and Nagaland, and

since SACSs have many other responsibilities, blood safety functions may not be

receiving adequate attention (Ramani et al., 2009).

of 115

• Conceptually creation of the state of the art and model blood banks is ideal and the

structure trickling down to the peripheries in the form of blood storage centres

forms a good pyramid. However, implementation of standard practice, quality

systems, teaching and research requires a tremendous amount of manpower –

which we currently lack. Infrastructure will be the easiest part of the algorithm to

create. Follow through to ensure accountability on all these fronts is vital.

• There is a huge disparity in the availability of BTS services at the state level. The less

developed states like UP, Orissa, Jharkhand, MP have lesser number of blood banks

that has a direct link with the blood units collected(Refer Fig 4 and 7). Especially

availability of blood transfusion services in the geographically remote areas and

difficult terrain particularly bear the brunt of this inequity.

6.2 Demand and Supply

It is evident that the gap between demand and supply is narrowing down. However, there

are still issues that need to be addressed.

• It is evident that currently there is a mismatch between demand and supply of blood

and its products. Literature also reveals that deaths are reported at childbirth or in

accident cases, due to lack of timely availability of blood. Surgeons, obstetricians and

other qualified clinicians are now available in rural areas who are handicapped in

saving these lives because of non-availability of blood (CDSCO, 2013).

• It is also predicted that the demand will increase due to the ageing population, high

rates of accidents and injuries(Williamson & Devine, 2013)

• New approaches to recruitment and detainment of future generations of blood

donors are needed. Integrated approaches in bloodstock management between

transfusion services and hospitals are critical to minimize wastage-E.g. Using supply

chain solutions from industry (Williamson & Devine, 2013).

of 115

6.3 Transfusion Transmitted Infections

• Screening blood for Hep B surface antigen alone which is currently mandatory in

India has little impact on reducing post transfusion Hepatitis. Hep B surface antigen

is considered as less effective in screening, and there is a possibility of missing out a

significant amount of cases. Whereas other developed and few other developing

countries, follow core antibody screening.

• There is no standard method prescribed for Malaria screening. The current practice

is screening Malaria by any acceptable method. Generally, peripheral smear is being

done and very few centres are practicing ELISA. But for those centres that collect

huge volume of blood, screening Malaria is labour intensive.

• In India, there is no system or an action plan for follow up if the patient is found to

be positive.

6.4 Augmentation of Voluntary Blood Donation(VBD)

There are several factors hindering voluntary blood donation that need to be addressed on

order to achieve the adequate, safe and quality blood and blood products

• Even though Indian law forbidden collection of blood from paid donors, many times

health care facilities are forced to accept blood from paid donors as there is scarcity

of voluntary blood donors (Sabu KM, 2011). There are several factors affecting the

voluntary blood donation in the country. Although many individuals are eligible to

donate blood, numerous awareness campaigns promote its importance and a good

proportion of the population shows a positive attitude towards blood donation; only

a smaller proportion actually ever donates blood voluntarily (Riley, Schwei, &

McCullough, 2007). It was observed that higher the income, percentage of non-

donors was high, which means it is the poor unemployed and servicing people who

are the backbone of the blood donation programme (Shah, Pallavi Patil, Deepika

Sawant, Madhavi Deokar, & Puranik, 2011). Physical harm, fear, possible illness, and

inconvenience of giving blood were found to be the common reasons for not

of 115

donating blood (Juarez-Ocana, Pizana-Venegas, Farfan-Canto, Espinosa-Acevedo, &

Fajardo-Gutierrez, 2001; Singh Bir, 2002). Another study reports that the hesitation

towards blood donation is mainly due to inadequate and incorrect knowledge for its

necessity and misconceptions (Shenga, Pal, & Sengupta, 2008). The interaction with

staff of health facilities is also considered as One of the important factors motivating

people for donating blood (Mullah, Kumar, Antani, & Gupta, 2013). Fear of learning

HIV status and mistrust of confidentiality are also considered as obstacles to blood

donation many places. The widely prevalent indigenous fear is (“khoon ki kami “ or a

volumetric deficiency of blood) one of the important reason for not donating blood

(Sharma, 2011).

• Nationally, in the donor profile, youngsters and females are underrepresented. SIMS

data also indicates the same. The involvement of youngsters is essential to ensure

repeat donations (Sharma, 2011). Strategies to increase the donation rates among

the younger generation, increase the number of repeat donors and to secure wider

community support for blood donation are required.

• Strategies to increase the awareness on the importance of blood donation among

young people, including high-school students and young mothers are required.

• IEC materials need to focus on providing correct knowledge and to clarify the myths

and misconception prevailing in the community.

6.5 Access to safe and Quality Blood

There has been a substantial improvement in the access to safe and quality blood and blood

products thanks to the increased number of blood banks, blood storage centres, etc.

Nevertheless, efforts are required to achieve universal access to blood and blood products

in the country.

• Though the country has ensured blood banks in all the districts, blood banks are still

not available or not-functional in some districts (NACO, 2013). Several government

of 115

blood banks in India operate in hospitals with minimal infrastructure and

inadequate/irregular supply of blood (Ramani et al., 2009; Vora et al., 2009)

• Especially, rural areas do not have licensed blood banks or resources to build them,

and most of the licensed blood banks are urban centric that make blood and blood

products inaccessible to the rural population. The Supreme Court Judgment in 1996

resulted in improvements in blood safety, but it made blood even scarcer in rural

areas as more than necessary infrastructural requirements were mandated for

licensing blood-banks. The policy changes to have small blood-storage facilities have

not made significant advancements due the non-achievements of BSCs as planned,

lack of surplus blood available at link blood-banks and lack of coordination and

understating between the blood-bank and the blood-storage units (Vora et al.,

2009). In addition due to high level of illiteracy, poverty and superstition, very few

people are ready to donate blood in rural India (Mavalankar, 2004).

• In peripheral areas, there are few organized services, and the HIV testing facility is

sometimes a considerable distance from the blood centre – the transport and

screening of blood samples can take several days (Bray & Prabhakar, 2002).

• There is also evidence that there is a huge state level disparity in the availability

services facilities, blood and blood products. Some of the less developed states

recorded very low levels of blood units per 100,000 populations that may make the

services inaccessible to a high proportion of the population.

• The recent policy changes to charge the patients the processing fee is a major barrier

to accessing blood by poor women who need it, especially in emergency (Vora et al.,

2009).

• The blood banks need to be also more efficient as even with less number of blood

banks with efficient functioning and network; the lack of access to safe blood can be

easily addressed by having more and properly trained manpower and good supply

chain management system.

of 115

6.6 Quality Assurance in Blood Transfusion Services

The quality assurance related issues, challenges and recommendations are,

• In spite of several quality assurance mechanisms, the annual reports of Departments

of AIDS Control in 2009-10, 2010-11 and 2012-13 have repeatedly mentioned the

deficiencies based on the assessment of blood banks, such as, lack of proper

infrastructure and facilities, lack of manpower, frequent transfer of trained

manpower to other departments, poor accessibility, inadequacy, poor safety and

poor quality maintenance, absence of Quality Management System, lack of

standardization, poor maintenance of inventory of equipment, kits and consumables

and improper record keeping and documentation (NACO, 2010) (NACO, 2011b)

(NACO, 2013). It indicates that the above problems exist for a longer time period

which may be given attention.

• Implementation of the Internal Quality Control Program should establish written

policies and procedures, assign responsibility for monitoring and reviewing, train

staff, collect data and set evidence based targets. In addition the need to establish

and implement troubleshooting and corrective action protocols and maintain a

system for documentation is also essential (Jain et al., 2013).

• Literature suggest that there is a lack of uniform quality-assurance processes like,

manuals for standard operating procedures, appropriate training and competency

certification programmes and continuous assessment systems, hamper good

laboratory and manufacturing practices. It was also reported that BTS service units

have different testing procedures and standards which hindered the exchange of

blood between blood banks hence leading to wastage of blood (Ramani, Mavalankar,

Tirupati, & Chand, 2008).

• It is also suggested for an ordered law for infrastructure and storage and to ensure

compliance and quality assurance. Since quality assurance is a legal obligation in

mandating good practices in blood banks, it is essential to update the rules, maintain

a uniform approach for self-sufficient supply, product quality and transfusion safety.

(Pal et al., 2011)

• As mentioned elsewhere, there are huge numbers of private blood banks available in

of 115

the country which are not strictly under the purview of Department of AIDS Control.

The status of quality assurance practices are not known or nor clear. Efforts are

required to bring all the blood banks under one umbrella so that monitoring,

supervision and quality assurance can be ensured.

6.7 Monitoring and Evaluation System of Blood Transfusion Services in India

• Though DAC supported blood banks are being monitored and supervised at district,

state and national level, private sector blood banks are not being monitored and

supervised at different levels.

• Several private and voluntary blood banks are not reporting to Department of AIDS

Control through Strategic Information Management Systems which prevents the

country to get a national scenario of volume of blood collected, TTIs, and component

separation.

6.8 Appropriate Use of Blood and Blood Produces – Clinical use of Blood and

Blood products

• In terms of appropriate use of blood and blood products, India is lacking in several

fronts. There is a need for comprehensive national guidelines on the appropriate

clinical use of blood and blood products; a national haemovigilance system;

mandatory Transfusion committees in all hospitals performing transfusions; and

mandatory clinical audit in all the hospitals performing transfusion and there should

be a system for reporting adverse transfusion events in all the hospital.

• The use of whole blood need to be reduced to the maximum possible extent so that

the cost as well as risk due to blood transfusion can be minimized. Studies indicate

that, of all blood components, Fresh Frozen Plasma showed a maximum

inappropriate usage, which needs to be addressed (Gomathi & Varghese, 2012).

• Blood components can be obtained by aphaeresis rather than prepared from a

standard unit of whole blood (Singhal, Patel, Kapoor, & Mittal, 2013)

of 115

• In order to reduce inappropriate use of blood and blood products, it is suggested to

establish of transfusion practice guidelines; Retrospective monitoring of medical /

transfusion records of the patients; Prospective monitoring of requests for blood

components before they are issued; introduction of new transfusion policies or

algorithms; Education of health professionals; and Peer review and self-audit

(Chaudhary, 2013).

• It is evident that great proportions of wastage happen in India due to expiry,

breakage and red blood cells contamination for fresh frozen plasma. A

comprehensive inventory management system and up gradation of facilities and

training of staff is necessary to ensure optimum utilization and minimize wastage

(Singhal et al., 2013).

6.9 Technological Innovations in Blood Transfusion Services in India

• India is quick and effective in adapting newer technologies and implementing

innovations. But, benefits of these reach only a smaller section of the society. There

is a huge inequity in access to technology and innovations across the country. Many

technological adaptations are individual hospital centric and limited to particular

geographical area.

• E-blood banking is found to be effective. But, it is critical that a nationally unified

system of integrated e-blood banking system is in place to regularize systems and to

improve the efficiencies.

6.10 Integration with the Health System and Convergence with NRHM, other

departments and Ministries

• It is evident that several health facilities including DHs, CHC and FRUs lack of blood

bank/blood storage facilities (GOI, 2013; IIPS, 2005, 2010) which calls for more

efforts on convergence.

of 115

• The mechanism of availability of blood in rural areas is quite weak. There is a need

for networking between urban blood-banks and rural blood-storage units. And as

there is no special provision for timely blood supply for maternal emergencies in

rural areas, it may not be possible to reduce maternal mortality due to hemorrhage,

anaemia, and abortions. The use of blood components, at least in urban areas where

facilities exist for storage of components, will also enhance supply of whole blood for

rural areas (Ramani et al., 2009).

• Convergence of BTS services with other National Disease Control Programmes need

to be given more attention. A convergence plan between DAC and other

programmes and a comprehensive blood safety plan in coordination with other

departments like Social Welfare, Education, and Youth will make the implementation

effective.

6.11 Efficient Supply Chain Management and Quality Assurance

• There have been many incidents of test kit stock out complaints reported in 2012

and 2013 (TheHealthsite, 2013). Due to the absence of centrally procured diagnostic

kits, Department of AIDS Control has authorized local purchase by blood banks in

order to maintain uninterrupted supplies (Krishnan, 2013). Decentralization of

procurement will be more effective as there will be more ownership from the states.

• There is a lack of coordination between blood banks, blood storage centres and

health care facilities due to the fragmented systems. Lack of clear guidelines to

transfer blood and blood products to one high volume blood banks to low volume

blood banks and blood storage centres.

• A centralised and a comprehensive e-Blood Bank Management System which can

strengthen effective stock utilization and supply chain management. This can also

facilitate easy prescription of blood transfusion, faster turnaround time from

demand to issue, locating the blood components thus increasing transfusion

of 115

security. This will also ease up the monitoring, facilitate better planning and resource

allocation (Wankhede, 2013)

6.12 Legal, Regulatory and Policy Dimension of Blood Transfusion Services in

India

• In spite of the legislations, compliance with quality assurance and Good

Manufacturing Practices is not ensured, 34% of blood banks are unlicensed and

nearly 50% of collection is estimated to be from paid blood sellers and only 5% of

voluntary donors are repeat donors. There is a need for ordered law for

infrastructure and storage for compliance and quality assurance.

• Though mandated by law, all donated blood units are not screened for TTI. Testing

for TTIs is unsatisfactory and poorly regulated in India. Reporting of adverse events

after transfusion is poor and no stringent donor deferral system exists (Kapoor,

Saxena, Sood, & Sarin, 2000; Ray, Chaudhary, & Choudhury, 2000b).

• Poor regulation, monitoring and control of blood bank exist because of the

involvement of multiple agencies for licencing, regulation etc. There is a need for an

independent Blood Transfusion Authority, to monitor the collection, storage,

distribution and supply of safe blood in the country.

• The Supreme Court judgement in 1996 advised the government to consider the

advisability of enacting legislation to regulate the collection, processing, storage,

distribution of blood, and the operation of blood banks. This is yet to happen.

• India does not have a National Blood Law though there is a national policy, in order

to ensure enforcements of GMP and GLP in optimal quality (Pal et al., 2011). This

calls for a national blood law.

• Currently, though buying and selling of blood is banned, anecdotal evidences

indicate that the business of paid blood donation continues to exist which indicate a

of 115

genuine lacuna in the law enforcement. Though the Supreme Court banned

commercial blood donation, it did not stipulate any punishment.

• The Indian National Blood Transfusion Services Act 2007, prepared by the Union

health ministry may be reviewed and proposed in the parliament

of 115

7. Key recommendations of experts based on site visit observations

7. I). Policy Level

• The experts expressed that guidelines need to be converted into rules with a

mechanism to ensure its compliance.

• The National Blood Transfusion Council and the State Blood Transfusion Council

should be bestowed with authority to take corrective measures and actions against

non-conforming blood banks either directly or through the Licensing body.

• There should be some mechanism/criteria to support larger blood banks in terms of

Infrastructure, human resources and automation need

• It is important to develop one or two blood banks in a specific region into major

blood bank(s) with component separation facilities, and the other smaller ones to be

either storage units attached to the same and/or collection centres that feed the

major blood banks.

• Unbanked Direct Blood Transfusion: It is vital to assess the practice of direct donor to

recipient transfusion and the reasons for that. The existing status policy, legal and

regulatory mechanism in terms of this practice need to be revisited to ensure

universal access to safe and quality blood and blood products.

• Transport of blood units: Policy regarding cross border transportation of blood is not

very clear. Liabilities to be stated and appropriate documentation to be put in place.

7. II). Program Level

• Capacity Building: Frequent transfers of staff mandate a continuous plan in order to

train the blood bank staff. In specific, advanced training especially on Internal Quality

Control and External Quality Assurance System (EQAS) for the staff is very much

required. Department of AIDS Control may consider periodical continuing medical

education (CME) programme which may be linked with accreditation.

of 115

• Supply of equipment: Department of AIDS control and State AIDS Control Societies

DAC/ SACS should undertake a comprehensive infrastructure needs assessment and

obtain the consent of Blood Bank/ Medical Superintendent before the supply of

equipment to blood banks. It will be waste of resources if equipment are dumped

without assessing the requirement. There should be a clear mechanism to obtain

license for certain equipment which are currently defunct in many blood banks for

want of licensing.

• Maintenance of equipment: Department of AIDS Control should provide appropriate

guidelines and training on maintenance of the costly equipment and planning for

maintenance contracts.

• Voluntary blood donation: It is imperative that DAC should develop a strategic plan

for the implementation of programs in order to accelerate the voluntary blood

donation particularly in north & north eastern states.

• Rational use of blood and products: DAC needs to have a strategic plan to sensitize

the clinicians on rational use of blood and products in order to increase the demand

for component usage. CME and regular workshops for clinicians may be considered.

• Data collection & reporting: DAC should develop a structured plan to facilitate

individual facilities to analyse the collected data and make use of them for taking

corrective measures and for programme planning.

• External Quality Assurance System (EQAS): Quality assurance should be non-

punitive with education. The participants in the EQAS program need to coordinate

more effectively. A comprehensive EQAS programme which include TTI testing and

Immunohematology is essential.

• Referral and Linkages: : There should be a clearly defined structured mechanism for

networking between Government, private & charitable hospitals in order to address

the needs and demands. Blood Banks should be linked with other blood banks in the

of 115

area to meet the demand in case of crisis and exchange the excess available blood

which will improve the accessibility.

• Accreditation: It is very essential that Department of AIDS Control and the State

AIDS Control Societies have a clearly defined strategy and action plan to motivate

and facilitate accreditation of blood banks.

7. III). Institution Level

• Staff availability: The inadequacies in staff positions need to be addressed by the

head of the institution.

• Voluntary blood donors list: The hospital authorities should take necessary steps to

compile the list of potential repeat blood donors and develop local mechanism to

remind them for donation especially during high demand seasons.

• Adherence to SOP: The hospital authorities should ensure that SOPs are regularly

updated and validated by the competent authority. It should be displayed in their

respective areas of activity in the blood banks. Efforts are needed to ensure

compliance to SOPs.

• Calibration of equipment: The blood bank authorities should ensure that all

equipments are calibrated as per the standards at required frequencies.

• Testing Techniques: It is important to ensure that that blood banks discontinue the

slide/ tile method for blood grouping and opt for direct and reverse blood grouping

by tube technique. Facilities should also be provided for red cell antibody

identification.

• Universal precautions: Few blood banks are not aware of the percentage of

hypochlorite used for disinfection and spill treatment. The SOPs for bio-safety and

segregation of waste are also not available in few facilities especially for discarding

of sero-reactive blood. The hospital authorities should ensure that, universal

precautions and appropriate biomedical waste management practices are followed

in the Blood Bank as per DAC guidelines.

of 115

• Coordination: Better coordination is required between SACS and Hospital authorities

for effective utilisation of resources (e.g. linkages with ICTC for communication of

sero-reactive donors, counselling of sero-reactive donors for Hep B & C, etc)

• Fund utilisation: The blood bank medical officer should be given more authority to

judiciously use the funds.

• Renewal of license: The hospital authorities should ensure that the blood bank

license is renewed in time.

8. Key areas for improvement and suggestions by Programme Officers of

SACS

• Manpower and responsibilities: It was suggested that the positions in SACS need to

be filled by senior Government officials on deputation, not by employing contract

staff. There is an urgent need to ensure adequate doctors and lab technicians. The

role of quality manager is vital that requires good knowledge on pharmacy; and

should be responsible for ensuring quality of equipment/testing. Supplies for the

blood banks should be managed by the hospital store keeper. The remuneration of

VBD consultants and Quality Managers should be on par with Deputy Director. The

JDs suggested that the blood bank medical officer needs to be given adequate

authority to make decision and handle local administrative issues.

• Training Programs: Government staffs need training and they should be encouraged

to attend training programs. It is also essential to include private blood banks in

training programs.

• Policy on Supplies: The policy on supplies needs to be consistent and intimated to

blood banks. Clear rules and guidelines on exchange of blood units between blood

banks are required.

of 115

• Reporting: The JDs felt that it is imperative and necessary to include private blood

banks in the existing reporting mechanism.

• Up gradation of facilities: In order to improve the access of blood and blood

components, there should be at least one blood bank per district. Major blood

banks/ DLBBs with greater requirement for components should be upgraded as

BCSU. Storage centres need to be set-up in remote areas with mobile blood donation

vehicles.

9. Conclusions

The provision of safe and adequate blood and blood products is vital to any health care

system and it is the responsibility of the government to ensure safe and quality blood and

blood products to those who in need. After the inception of National AIDS Control

Organization in 1992, Blood safety has been given utmost improvement. Due the concerted

efforts of different stakeholders, the blood transfusion services in India have improved very

significantly over the last two decades. There has been huge improvement in the

infrastructure, number of manpower, capacity, quality of testing kits and reagents,

availability of advanced equipment which in turn improved the services provision and

increased the access to safe and quality blood and blood products. In addition, there has

been an improved legal, and policy environment in the country that facilitates the effective

delivery of blood transfusion services. This can be very well understood from the fact that

the availability of safe blood increased from 44 lakh units in 2007 to 93 lakh units by 2012;

during this time HIV sero-reactivity also declined from 1.2% to 0.2%; and Voluntary blood

donation increased substantially (NACO, 2013).

Nevertheless, there are still gaps in the provision of Blood transfusion Services. For instance

there is an absence of a centralized management of blood services which results in lack of

standardized practices and processes. There are varying levels of capacities of the

personnel, poor quality standards, inadequacy of blood availability and presence of

geographical, economics, physical and gender related inaccessibility of blood transfusion

of 115

services those who are in need. There are still several changes required in the legal and

policy areas in order to make the blood transfusion services universally accessible to all.

It is essential that all the relevant stakeholders under the leadership of Department of AIDS

Control work together to address the gaps and challenges and ensure universal access to

safe and quality blood and blood products.

of 115

10. References

Agarwal, S. P. (2012). National Voluntary Blood Donation Day- Message of The Secretary

General. from http://www.indianredcross.org/sg-message-27-sep-2013.htm

Aggarwal S, S. V. (2012). Attitudes and problems related to voluntary blood donation in

India: A short communication. Ann Trop Med Public Health, 5(50).

Allain, J.-P. (2011). Moving on from voluntary non-remunerated donors: who is the best

blood donor? British Journal of Haematology, 154(6), 763-769. doi: 10.1111/j.1365-

2141.2011.08708.x

Ashavaid, T. F. (2012). Clinical Laboratory Medicine in India (Vol. 32).

Asthana, S. (1996). AIDS-related policies, legislation and programme implementation in

India. Health Policy Plan, 11(2), 184-197.

Bachani, D., & Sogarwal, R. (2010). National Response to HIV/AIDS in India. Indian J

Community Med, 35(4), 469-472. doi: 10.4103/0970-0218.74341

Baweja H, K. A. (1992, 30 November). The Indian face of AIDS. , India Today, p. 6.

Bharucha, Z. S., Jolly, J. G., Dhingra-Kumar, N., Wikanta, M., Pulimood, R., Singh, R., . . .

Emmanuel., J. C. (2006). Special Supplement: Blood Safety and Clinical Technology.

Indian Journal for the Practising Doctor, 3(1).

Bray, T. J., & Prabhakar, K. (2002). Blood policy and transfusion practice--India. Trop Med Int

Health, 7(6), 477-478.

CAG. (2004). National AIDS Control Programme - Ministry of Health and Family Welfare.

from http://www.cag.gov.in/reports/reports/civil/2004_3/chapter1.htm

CDC. (2011). Progress Toward Strengthening National Blood Transfusion Services — 14

Countries, 2008–2010. Morbidity and Mortality Weekly Report (MMWR), 60(46),

1578-1582.

CDSCO. (2013). Report of the 46th meeting of the Drugs Consultative meeting held on 12th

and 13th November 2013 at New Delhi. New Delhi: Central Drugs standard Control

Organization.

CDSCO. (2014). NUMBER OF LICENSED BLOOD BANKS IN THE COUNTRY UP TO November

2012. from http://www.cdsco.nic.in/forms/list.aspx?lid=1813&Id=1

of 115

Chandra, T., Rizvi, S. N. F., & Agarwal, D. (2014). Decreasing Prevalence of Transfusion

Transmitted Infection in Indian Scenario. The Scientific World Journal, 2014, 4. doi:

10.1155/2014/173939

Chandrashekar, S. (2014). Half a decade of mini-pool nucleic acid testing: Cost-effective way

for improving blood safety in India. Asian J Transfus Sci, 8(1), 35-38. doi:

10.4103/0973-6247.126688

Chaudhary, R. (2013). Rationale Use of Blood Components. Indian Journal of Transfusion

Medicine.

Choudhury, N. (2009). Management in Indian blood banking system: True reality. Asian J

Transfus Sci, 3(2), 57-59. doi: 10.4103/0973-6247.53871

Choudhury, N. (2011). Blood transfusion in borderless South Asia. Asian J Transfus Sci, 5(2),

117-120. doi: 10.4103/0973-6247.83234

Choudhury, N., Tulsiani, S., Desai, P., Shah, R., Mathur, A., & Harimoorthy, V. (2011). Serial

follow-up of repeat voluntary blood donors reactive for anti-HCV ELISA. Asian J

Transfus Sci, 5(1), 26-31. doi: 10.4103/0973-6247.75979

Correa;, M., & Gisselquist, D. (2005). HIV from Blood exposures in India. Colombo: NCA

South Asia, Colombo.

Das B K, G. B. K., Aditya Subhra, Chakrovorty Sumit Kumar, Datta P K, Joseph Ajay (2011).

Seroprevalence of Hepatitis B, Hepatitis C, and human immunodeficiency virus

among healthy voluntary first-time blood donors in Kolkata. Annals of Tropical

Medicine and Public Health, 4(2), 86-90.

Dhot, P. (2003). Amendments to Indian Drugs and Cosmetics Act and Rules Pertaining to

Blood Banks in Armed Forces. MJAFI, 61, 264-266.

eIndia. (2012). e-Blood Bank, an Integrated Blood Bank Automation System of Govt. of

Odisha – State Blood Transfusion Council, Odisha. Paper presented at the e India

India's largest ICT event, Hyderabad. http://eindia.eletsonline.com/2012/e-blood-

bank-an-integrated-blood-bank-automation-system-of-govt-of-odisha-national-rural-

health-mission-nrhm-department-of-health-and-family-welfare-government-of-

odisha/

Elhence, P. (2006). Ethical issues in transfusion medicine. Indian Journal of Medical ethics,

3(3).

GIZ. (2012). Reform Indian blood transfusion system

of 115

GOI. (2001). GUIDELINES FOR APPROVAL OF BLOOD AND/OR ITS COMPONENTS TO

STORAGE CENTRES AND FIRST REFERRAL UNIT, COMMUNITY HEALTH CENTRE,

PRIMARY HEALTH CENTRE OR ANY HOSPITAL: Ministry of Health & Family Welfare

(Deptt. of Health) vide Notification No. GSR 909(E) dated 20th December, 2001

GOI. (2003). Transfusion Medicine, Technical Manual. New Delhi: Director General of Health

Services, Government of India.

GOI. (2004). Guidelines for operationalising first referral units. New Delhi: Maternal Health

Division, Department of Family Welfare, Ministry of Health and Family Welfare,

Government of India.

GOI. (2007). Evaluation Study of National Rural Health Mission (NRHM) In 7 States. New

Delhi: Planning Commission Retrieved from

www.planningcommission.nic.in/reports/peoreport/peoevalu/peo_2807.pdf .

GOI. (2011). Report of the Working Group on National Rural Health Mission (NRHM) for the

Twelfth Five Year Plan (2012-2017). New Delhi: Planning Commission, Government

of India.

GOI. (2013). Health and Family Welfare Statistics in India-2013. New Delhi: Statistics

Division, Ministry of Health and Family Welfare, Government of India.

GOM. (2005). Blood Transfusion Services - Maharastra. Maharastra: SBTC, Maharastra.

GOM. (2014). Law and Transfusion Service. from http://www.mahasbtc.com/law-and-

transfusion-service

Gomathi, G., & Varghese, R. G. (2012). Audit of use of blood and its components in a tertiary

care center in South India. Asian J Transfus Sci, 6(2), 189. doi: 10.4103/0973-

6247.98952

GOO. (2014). State Blood Transfusion Council. from

http://203.193.146.66/hfw/SBTC.asp?GL=3

GSBTC. (2013). REGIONAL BLOOD TRANSFUSION CENTRES - GSCBT Gujarat: Gujarat State

Blood Transfusion Council.

Gupta, R., Singh, B., Singh, D. K., & Chugh, M. (2011). Prevalence and trends of transfusion

transmitted infections in a regional blood transfusion centre. Asian J Transfus Sci,

5(2), 177-178. doi: 10.4103/0973-6247.83250

Gupte, S. (2002). Recent Advances in Pediatrics: Community pediatrics: Jaypee Brothers.

of 115

Hazarika, S., & Dutta, A. R. (2013). Healthcare Technology: A Domain of Inequality. Advances

in Applied Sociology, 3, 85.

Hemogenomics. (2013). Blood safety. from

http://www.hemogenomics.com/index.php/blood-safety

Hess, J. R., & Thomas, M. J. (2003). Blood use in war and disaster: lessons from the past

century. Transfusion, 43(11), 1622-1633.

HINDU, T. (2007). Blood storage centres to reduce maternal mortality. 2007.

IBTO(2013) ECO Blood Safety Network Iranian Blood Transfusion Organization, International

Affairs Department

IBMS. (2014). A brief history of blood transfusion. from

http://www.ibms.org/go/nm:history-blood-transfusion

ICMR. (1987). Sero-surveillance for HIV infection in India. ICMR Bulletin, 17(12).

IIPS. (2005). FACILITY SURVEY (Under Reproductive and Child Health Project) Phase – II,

2003. Mumbai-88: International Institute for Population Sciences, (Deemed

University) and Ministry of Health and Family Welfare, Government of India, New

Delhi.

IIPS. (2010). District Level Household and Facility Survey 2007-08. Mumbai: International

Institute for Population Sciences and Ministry of Health and Family Welfare,


IRCS. (2014). Programmes. from http://www.indianredcross.org/program.htm

Jain, R., Sharma, V., & Gupta, G. N. (2013). Internal Quality Control In Blood Bank Testing.

Indian Journal of Transfusion Medicine.

Juarez-Ocana, S., Pizana-Venegas, J. L., Farfan-Canto, J. M., Espinosa-Acevedo, F. J., &

Fajardo-Gutierrez, A. (2001). [Factors that influence non-donation of blood in

relatives of patients at a pediatric hospital]. Gac Med Mex, 137(4), 315-322.

Kapoor, D., Saxena, R., Sood, B., & Sarin, S. K. (2000). Blood transfusion practices in India:

results of a national survey. Indian J Gastroenterol, 19(2), 64-67.

Kaur, P., Basu, S., Kaur, G., & Kaur, R. (2013). Transfusion issues in surgery. Internet Journal

of Medical Update, 8(1), 46-50.

Kora S.A., K. K. (2011). An Analysis of Donor Blood Wastage in a Blood Bank in Rural

Karnataka. Journal of Clinicl and Diagnostic Research, 5(5).

of 115

Krishnan, V. (2013). Govt blood banks won’t be able to guarantee safety for next 90 days.

from http://www.livemint.com/Politics/dNYq2bxFq56TFYhz2Nl5SL/Govt-blood-

banks-wont-be-able-to-guarantee-safety-for-next.html

Lowalekar, H., & Ravichandran, N. (2013). Blood bank inventory management in India.

OPSEARCH, 1-24. doi: 10.1007/s12597-013-0148-z

Mavalankar, D. V. (2004). Policy Barriers Preventing Access to Emergency Obstetric Care in

Rural India. Working Paper Series. Ahmedabad.

MedicalBuyer. (2014a). Blood Cell Separators: Delivering Innovation.

MedicalBuyer. (2014b). Blood Collection Equipment And Ancillaries:A Steady Market. from

http://www.medicalbuyer.co.in/index.php?option=com_content&task=view&id=495

9&Itemid=48

MOH (Ed.). (2009). Hand Book Of National Guidelines On ‘Appropriate Clinical Use of Blood’

For Doctors, Assistant Clinical Officers and Nurses. Bhutan: Ministry of Health.

Mohanty, D. (2011). Online, all you wanted to know about blood in Orissa,

TheIndianExpress. Retrieved from http://archive.indianexpress.com/news/online-all-

you-wanted-to-know-about-blood-in-orissa/889679/

Mullah, F., Kumar, D., Antani, D., & Gupta, M. (2013). Study of Knowledge, Perceptions and

Practices Related to Blood Donation Among the Healthcare Support Staff of a

Tertiary Care Hospital in Gujarat, India. Online Journal of Health and Allied Sciences,

12(1).

NACO. (1993). National AIDS Control Programme India. Country Scenario: an update. New

Delhi: National AIDS Control Organization, Ministray of Health and Family Welfare,


NACO. (2003). National Guidebook on Blood Donor Motivation. New Delhi: National AIDS

Control Organization, Ministray of Health and Family Welfare.

NACO. (2006). Strategy and Implementation Plan-National AIDS Control Programme Phase

III. New Delhi: Department of AIDS Control, Ministry of Health and Family Welfare,


NACO. (2007a). An Action Plan for Blood Safety. New Delhi: National AIDS Control

Organization, Ministray of Helath and Family Welfare.

NACO. (2007b). Guidelines For Setting up Blood Storage Centres. New Delhi: National AIDS

Control Organisation, Ministry of Health and Family Welfare, Government of India

of 115

NACO. (2007c). Manual on quality standards for HIV Testing laboratories. New Delhi:

National AIDS Control Organization, Ministry of Health and Family Welfare,


NACO. (2007d). National Blood Policy (India). New Delhi: National AIDS Control

Organization, Ministry of Helath and Family Welfare.

NACO. (2007e). Operational Manual for Strategic Information Management Unit(SIMU).

New Delhi: National AIDS Control Organization, Ministry of Health and Family

Welfare, Government of India.

NACO. (2007f). Procurement Manual for National AIDS Control Programme (NACP III) New

Delhi: National AIDS Control Organization, Ministry of Health and Family Welfare,


NACO. (2007g). Project Implementation Plan for National AIDS Control Programme, Phase-III

(2007-12). New Delhi: Department of AIDS Control, Ministry of Health and Family

Welfare, Government of India.

NACO. (2007h). Standards For Blood Banks & Blood Transfusion Services. New Delhi:

National AIDS Control Organisation, Ministry of Health and Family Welfare,

Government of India

NACO. (2010). NACO Annual Report 2009-10. New Delhi: National AIDS Control

Organization, Ministry of Health and Family Welfare, Governemnt of India.

NACO. (2011a). Annual Report 2010-11. New Delhi: National AIDS Control Organization,

Ministray of Health and Family Welfare.

NACO. (2011b). NACO Annual Report 2010-11. New Delhi: National AIDS Control

Organization, Ministry of Health and Family Welfare, Governemnt of India.

NACO. (2013). Annual Report 2012-13 New Delhi: Department of AIDS Control, Ministry of

Health & Family Welfare, Governemnt of India.

NACO. (2014a). Access to Safe Blood. from

http://www.naco.gov.in/NACO/National_AIDS_Control_Program/Services_for_Preve

ntion/Access_to_Safe_blood/

NACO. (2014b). Blood Safety- Master Sheet. Department of AIDS Control, Ministry of Health

and Family Welfare. New Delhi.

of 115

NACO. (2014c). Minutes of the Meeting for Plasma Fractionation Centre and Plasma Policy.

New Delhi: Department of AIDS Control, Ministray of Health and Family Welfare.

NACO. (2014d). NACP IV Targets. from http://www.naco.gov.in/NACO/NACP-

IV2/NACP_IV_Targets/

NACO. (2014e). National AIDS Control Programme Phase-IV (2012-2017) Strategy

Document. New Delhi: Department of AIDS Control, Ministry of Health and Family

Welfare, Governemtn of India.

NACO. (2014f). National AIDS Control Programme Phase IV (2012-2017). New Delhi:

Department of AIDS Control, Ministry of Health and Family Welfare, Government of

India.

Nanu, A. (2001). Blood transfusion services: organization is integral to safety. Natl Med J

India, 14(4), 237-240.

NIB. (2012). GUIDANCE DOCUMENT FOR REPORTING SERIOUS ADVERSE REACTIONS IN

BLOOD TRANSFUSION SERVICE. Noida: National Institute of Biologicals, Ministry of

Health and Family Welfare, Government of India

NRHMOrissa. (2014). e-Blood Bank - An integrated Blood Bank Automation System. from

http://ebloodbank.nrhmodisha.in/

Pal, R., Kar, S., Zaman, F. A., & Pal, S. (2011). The quest for an Indian blood law as of blood

transfusion services regulatory framework. Asian J Transfus Sci, 5(2), 171-174. doi:

10.4103/0973-6247.83246

Pandey, K. (2014). Drugs advisory board says no to direct blood transfusion. Down to Earth.

Phadnis, R. (2013). Make NAT must for blood banks in district: doctors. THEHINDU.

Prasannakumar. (2008). The National AIDS Control Programme (1, 2, 3). from

http://infochangeindia.org/hiv-aids/response/the-national-aids-control-programme-

1-2-3.html

Ramani, K. V., Mavalankar, D., & Govil, D. (2007). Management of Blood Transfusion

Services in India: An Illustrative Study of Maharashtra and Gujarat States: Indian

Institue of Ahmedabad, AHMEDABAD.

Ramani, K. V., Mavalankar, D., Tirupati, D., & Chand, V. S. (2008). Managerial Challenges in

Addressing HIV/AIDS: Gujarat State AIDS Control Society (GSACS): INDIAN INSTITUTE

OF MANAGEMENT, AHMEDABAD.

of 115

Ramani, K. V., Mavalankar, D. V., & Govil, D. (2009). Study of blood-transfusion services in

Maharashtra and Gujarat States, India. J Health Popul Nutr, 27(2), 259-270.

Ramkishan, A., Gupta, V. K., Koshia, H. G., Goswami, K. K., Shah, K. K., & Shah, R. J. (2012).

Effective implementation of regulations and facilitation in improving blood

transfusion services in Gujarat state. Asian J Transfus Sci, 6(2), 190-192. doi:

10.4103/0973-6247.98955

Ray, V. L., Chaudhary, R. K., & Choudhury, N. (2000a). Transfusion safety in developing

countries and the Indian scenario. Developments in biologicals, 102, 195-203.

Ray, V. L., Chaudhary, R. K., & Choudhury, N. (2000b). Transfusion safety in developing

countries and the Indian scenario. Dev Biol (Basel), 102, 195-203.

Registrar General, I. (2006). Maternal Mortality in India, 1997–2003: Trends, Causes and Risk

Factors: Sample Registration System. New Delhi, India: RGI.

Riley, W., Schwei, M., & McCullough, J. (2007). The United States' potential blood donor

pool: estimating the prevalence of donor-exclusion factors on the pool of potential

donors. Transfusion, 47(7), 1180-1188. doi: 10.1111/j.1537-2995.2007.01252.x

Sabu KM, R. A., Binu VS, Vivek R. (2011). Knowledge, Attitude and Practice on Blood

Donation among Health Science Students in a University campus, South India.

Journal of Health and Allied Sciences, 10(2).

Sarin, M. L. (2003). The Blood Bankers’ Legal Handbook Retrieved from

http://sarins.org/wp-content/uploads/2009/06/bloodbankerslegalhandbook1.doc

Sarkar, R. S., Philip, J., Kumar, S., & Yadav, P. (2012). Evolution of the role of army

transfusion services in the management of trauma patients and battle casualties

with massive hemorrhage. Med J Armed Forces India, 68(4), 366-370. doi:

10.1016/j.mjafi.2012.07.002

SBTC. (2013). State Blood Transfusion Council, Department of Health and Family Welfare,

Orissa. from http://203.193.146.66/hfw/SBTC.asp?GL=3

Shah, V. B., Pallavi Patil, Deepika Sawant, Madhavi Deokar, & Puranik, G. V. (2011). A Study

of Public Perception towards Blood Donation. Bombay Hospital Journal,, 53(1), 34-

17.

Sharma, R. (2011). Psychosocial profiling of blood donors and assessing source of awareness

of blood donation through a blood donation camp at a medical college, Ahmadabad,

Gujarat. Asian J Transfus Sci, 5(2), 183-184. doi: 10.4103/0973-6247.83259

of 115

Shenga, N., Pal, R., & Sengupta, S. (2008). Behavior disparities towards blood donation in

Sikkim, India. Asian J Transfus Sci, 2(2), 56-60. doi: 10.4103/0973-6247.42692

Singh, A. S., Das, S.G: . (2007). Modern Blood Banking in India: A study of Prathama Blood

Centre. . Paper presented at the International Conference on Marketing and Society,,

IIMK (2007).

Singh Bir, P. R., DSouza N, Anushyanthan A, Krishna V, Gupta V, Chaudhary MM, Ganeshan

S, Jha S, Uppal S, Mehrara V, Deepchand RD, Singh Y, Hsia KM, Bhushan S, Anand V,

Singh AK (2002). Knowledge, Attitudes and Socio-Demographic Factors

Differentiating Blood Donors from Non-Donors in an Urban Slum of Delhi. Indian

Journal of Community Medicine, 27(3), 118-118.

Singhal, M., Patel, M., Kapoor, D., & Mittal, D. (2013). A research analysis on blood

component usage and wastage in blood bank and blood component center Journal

of Physiology and Pathophysiology, 4(2).

SolutionExchange. (2006). Blood Donation and HIV from Solution Exchange, UNDP

ftp://ftp.solutionexchange.net.in/public/aids/cr/cr-se-aids-01070601-public.doc

Tagny, C. T. (2012). The current need for family and replacement donation in sub-Saharan

Africa should not hide the difficulties of its management. Transfusion Medicine,

22(4), 298-299. doi: 10.1111/j.1365-3148.2012.01157.x

TheHealthsite. (2013). Is India’s HIV/AIDS success story a farce? , from

http://health.india.com/diseases-conditions/is-indias-hiv-aids-success-story-a-farce/

Tirupathi, K. (2013). Quality and safety come first’. e Health.

Tripathi, P. S. (2005). For a law on blood banks. Frontline, 22(14).

Umakanth Siromani, Thasian T, Rita Isaac, Dolly Daniel, Selvaraj K G, Joy John Mammen, &

Nair, S. C. (2013). Shortage of Blood! Youths, The Trend setters, Can they help to

meet the needs? National Journal of Medical Research, 3(2).

UN. (2001). Road map towards the implementation of the United Nations millennium

declaration, report of the secretary general, United Nations General Assembly. New

York: United Nations.

UNAIDS. (2012). India Report NCPI.

Vora, K. S., Mavalankar, D. V., Ramani, K. V., Upadhyaya, M., Sharma, B., Iyengar, S., . . .

Iyengar, K. (2009). Maternal health situation in India: a case study. J Health Popul

Nutr, 27(2), 184-201.

of 115

Wankhede, G. (2013). There is a Need for Centralised System. from

http://ehealth.eletsonline.com/2013/03/26621/

WHO. (1975). World Health Assembly resolution WHA28.72. Utilization and supply of

human blood and blood products: World Health Organization.

WHO. (2002). Blood Safety, Aide-Memoire for National Blood programme, . Geneva: World

Health Organization.

WHO. (2005). World Health Assembly resolution WHA58.13. Proposal for establishment of

World Blood Donor Day. Geneva: World Health Organization.

WHO. (2006). BLOOD TRANSFUSION SAFETY. Geneva.

WHO. (2008a). Universal Access to Safe Blood Transfusion (B. T. S. U. Department of

Essential Health Technologies, Trans.). Geneva.

WHO. (2008b). Universal Access to Safe Blood Transfusion WHO Global Strategic Plan 2008-

15. Geneva: World Health Organization.

WHO. (2008c). World Health Organization. Fact sheet no. 279. 2008. . Geneva: World Health

Organization.

WHO. (2009a). GDBS Summary Report 2009. Geneva: World Health Organization

WHO. (2009b). The Melbourne Declaration on 100% voluntary non-remunerated donation

of blood and blood components. Geneva: World Health Organization.

WHO. (2010a). Resolutions related to blood safety adopted by WHO governing bodies.

Geneva: World Health Organization.

WHO. (2010b). Screening Donated Blood for Transfusion-Transmissible Infections. Geneva:

World Health Organization.

WHO. (2010c). Towards 100% voluntary blood donation: a global framework for action.

Geneva: World Health Organization.

WHO. (2010d). World Health Assembly resolution WHA63.12. Availability, safety and quality

of blood products. Geneva: World Health Organization.

WHO. (2011). Developing a National Blood System. Geneva: World Health Organization.

WHO. (2012a). More voluntary blood donations essential [Press release]. Retrieved from

http://www.who.int/mediacentre/news/releases/2012/blood_donation_20120614/

en/

of 115

WHO. (2012b). Quality Systems for Blood Safety. Geneva: Department of Blood Safety and

Clinical Technology, World Health Organization.

WHO. (2012c). Strengthening Health Systems and Blood Services through a Primary Health

Care Approach. afsbtedu June 2012. Mauritius.

WHO. (2013a). Blood safety and availability. from

http://www.who.int/mediacentre/factsheets/fs279/en/

WHO. (2013b). The Rome Declaration on Achieving Self-Sufficiency in Safe Blood and Blood

Products, based on Voluntary Non-Remunerated Donation. Geneva: World Health

Organization.

WHO. (2013c). Towards Self-Sufficiency in Safe Blood and Blood Products based on

Voluntary Non-Remunerated Donation Global Status 2013. Geneva: World Health

Organization.

WHO. (2014a). Haemovigilance. from http://www.who.int/bloodsafety/haemovigilance/en/

WHO. (2014b). Safe and rational clinical use of blood. from

http://www.who.int/bloodsafety/clinical_use/en/

Williamson, L. M., & Devine, D. V. (2013). Challenges in the management of the blood

supply. The Lancet, 381(9880), 1866-1875.

Yasmeen, A. (2013). Spend Rs. 300 more and get safe blood. THEHINDU.

i This notification has been inserted under Schedule K of Drugs & Cosmetics Rules, 1945 under serial no. 5B. ii Ministry of Health & Family Welfare (Department of Health) vide Notification No. GSR 909(E) dated 20th Dec, 2001